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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.
 
DeviceCLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantINCSTAR CORP.
1990 INSUSTRIAL BLVD.
P.O. BOX 285
STILLWATER, MN 55082-0285
PMA NumberP790032
Supplement NumberS002
Date Received12/24/1990
Decision Date03/28/1991
Withdrawal Date 08/19/2002
Product Code LOK 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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