|
Device | ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36) |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2 DEPT 09VB ABBOTT PARK, IL 60064-3500 |
PMA Number | P970027 |
Supplement Number | S004 |
Date Received | 01/07/2005 |
Decision Date | 01/31/2005 |
Withdrawal Date
|
11/08/2013 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE MANUFACTURE AND TESTING FLOW OF INDEX CALIBRATOR. |