|
Device | ARCHITECT ANTI-HCV |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD AP5N-2, DEPT 09VB ABBOTT PARK, IL 60064 |
PMA Number | P050042 |
Supplement Number | S012 |
Date Received | 05/04/2011 |
Decision Date | 06/01/2011 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER. |