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 | AFP RIA KIT |
Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Applicant | ALERE, INC. 10 Southgate Road Scarborough, ME 04074 |
PMA Number | P760001 |
Supplement Number | S001 |
Date Received | 06/22/1982 |
Decision Date | 03/01/1984 |
Withdrawal Date
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07/20/2011 |
Product Code |
LOK |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
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