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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
(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