|
Device | ELECSYS ANTI-HCV IMMUNOASSAY |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P090007 |
Supplement Number | S002 |
Date Received | 04/11/2011 |
Decision Date | 05/04/2011 |
Reclassified Date
|
12/22/2021 |
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 TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT COMMON TO ALL DEVICES. |