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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Seraclone Control ABO+Rh; Coombscell-E; MLB2

Applicant: Biotest Medical Diagnostics GmbH

510(k) number: BK080012

Product: (1) Seraclone Control ABO+Rh

(2) Coombscell-E

(3) MLB2

Date: 7/23/2008

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Contact FDA

(800) 835-4709
(301) 827-1800
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-41

Rockville, MD 20852-1448
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