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 | FLUORO-CEP (R) PROGESTERONE |
Generic Name | KIT, ASSAY, PROGESTERONE RECEPTOR |
Regulation Number | 864.1860 |
Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 |
PMA Number | P900025 |
Supplement Number | S001 |
Date Received | 12/11/1991 |
Decision Date | 04/21/1992 |
Withdrawal Date
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03/26/2009 |
Product Code |
LPI |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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