ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36)
FDA premarket approval P970027/S004 · decided 2005-01-31
Approval details
- PMA number
- P970027
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36)
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories
- Date received
- 2005-01-07
- Decision date
- 2005-01-31
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGE IN THE MANUFACTURE AND TESTING FLOW OF INDEX CALIBRATOR.
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