|
Device | TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD |
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 | S012 |
Date Received | 09/23/1999 |
Decision Date | 09/29/1999 |
Reclassified Date
|
10/16/2002 |
Product Code |
MGU |
Advisory Committee |
Toxicology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding "Caution: This product contains natural dry rubber" to the labeling. |