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. |
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Device | GAMMA DAB (125I) AFP RIA KIT |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 STILLWATER, MN 55082-0285 |
PMA Number | P790032 |
Supplement Number | S001 |
Date Received | 06/10/1986 |
Decision Date | 08/22/1986 |
Withdrawal Date
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08/19/2002 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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