ABBOTT AXSYM ANTI-HCV
FDA premarket approval P970027/S008 · decided 2010-05-13
Approval details
- PMA number
- P970027
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT AXSYM ANTI-HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories
- Date received
- 2010-04-22
- Decision date
- 2010-05-13
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGE TO THE EFFICACY TESTING PERFORMED ON NEW INCOMING LOTS OF CONJUGATE CONCENTRATE FOR THE DEVICE.
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