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2006P-0402:
Determine that FDA would not Regulate as Medical Device Assays Developed
by Clinical Laboratories Strrictly for In-house Use (Home Brew)
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| ACK1
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| 10/02/2006
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| 10/02/2006
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| Federal Government
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| FDA/DDM to Washington
Legal Foundation (WLF)
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| pdf
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| Signature:
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| Jennie Butler
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| CP1
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| 10/02/2006
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| 09/28/2006
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| Consumer Group
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| Washington Legal Foundation
(WLF)
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| pdf
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| Signature:
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| Daniel J. Popeo and Richard
A. Samp
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| EC1
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| 04/02/2007
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| 03/02/2007
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| Other Organization
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| Dr. Ken Bloom
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| EC2
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| 04/02/2007
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| 03/23/2007
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| Other Organization
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| Hyman, Phelps
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| pdf
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| Signature:
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| Gibbs, Jeffrey N.
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| C1
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| 03/27/2007
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| 03/23/2007
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| Private Industry
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| Hyman, Phelps &
McNamara PC
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| pdf
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| Signature:
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| Jeffrey N Gibbs
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| EC3
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| 04/03/2007
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| 03/05/2007
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| Other Organization
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| Life Sciences Management
Group, Inc.
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| pdf
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| Signature:
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| Mackler, Bruce F.
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| EC4
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| 04/03/2007
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| 03/05/2007
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| Other Organization
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| National Tay-Sachs
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| htm
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| Signature:
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| Crawford, Kimberly
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Top
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Page last updated:
April 18, 2007
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