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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAB-CORE K HEPATITIS B CORE ANTIGEN 125I
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSorin Biomedica, Fiat, USA, Inc.
Fiat Usa Inc.
375 Park Ave.
Ny, NY 10152
PMA NumberP850044
Supplement NumberS002
Date Received08/01/1986
Decision Date10/31/1986
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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