|
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 | S009 |
Date Received | 01/16/1996 |
Decision Date | 04/01/1996 |
Reclassified Date
|
10/16/2002 |
Product Code |
MGU |
Advisory Committee |
Toxicology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement NEW PROBE CLEANING PROCEDURE |