Substantially Equivalent 510(k) Device Information
Applicant: American Blood Resources Association, Annapolis, MD
510(k) number: BK960030
Product: National Donor Deferral Registry
Date: 03/20/97
Summary of Safety and Effectiveness
510(k) Statement
I certify that, in my capacity as President of American Blood
Resources Association, I will make available all information
included in this premarket notification on safety and
effectiveness within 30 days of request by any person if the
device described in the premarket notification submission is
determined to be substantially equivalent. The information I
agree to make available will be a duplicate of the premarket
notification submission, including any adverse safety and
effectiveness information, but excluding all patient
identifiers, and trade secret and confidential commercial
information, as defined in 21 CFR 20.61.
--- signature --- __3/29/96_____
James P. Reilly (date)
President
American Blood Resources Association
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