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 | BIO-RAD CYCLOSPORINE BY HPLC TEST |
Generic Name | HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE |
Regulation Number | 862.1235 |
Applicant | Bio-Rad 4000 ALFRED NOBEL DR. HERCULES, CA 94547-1803 |
PMA Number | P880032 |
Supplement Number | S001 |
Date Received | 12/06/1990 |
Decision Date | 03/14/1991 |
Reclassified Date
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10/16/2002 |
Product Code |
MGS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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