|
Device | TDX/TDXFLX CYCLOSPORINE/METABOLITES 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 | S013 |
Date Received | 06/25/2001 |
Decision Date | 09/05/2002 |
Reclassified Date
|
10/16/2002 |
Product Code |
MGU |
Advisory Committee |
Toxicology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO PLACE INTO EFFECT THE UPDATED QUALITY CONTROL TEST FOR EVALUATING SHEEP ANTISERUM. |