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 | TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY |
Generic Name | Fluorescence polarization immunoassay for cyclosporine |
Regulation Number | 862.1235 |
Applicant | Abbott Laboratories ABBOTT LABS ABBOTT PARK, IL 60064 |
PMA Number | P890025 |
Supplement Number | S006 |
Date Received | 10/28/1992 |
Decision Date | 12/15/1992 |
Reclassified Date
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10/16/2002 |
Product Code |
MGU |
Advisory Committee |
Toxicology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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