|
Device | IMX TACROLIMUS II |
Generic Name | ENZYME IMMUNOASSAY, TRACROLIMUS |
Regulation Number | 862.1678 |
Applicant | Abbott Laboratories 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 |
PMA Number | P970007 |
Supplement Number | S003 |
Date Received | 07/30/2001 |
Decision Date | 09/05/2002 |
Reclassified Date
|
10/16/2002 |
Product Code |
MLM |
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 FOR CHANGES TO THE ABBOTT IMX TACROLIMUS II MASTER LOT TESTING. |