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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:  07/23/2008
 

Contact FDA

(800) 835-4709
(240) 402-8010
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002