HOME ACCESS HEPATITIS C CHECK TEST SYSTEM
FDA premarket approval P980046/S008 · decided 2011-08-31
Approval details
- PMA number
- P980046
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HOME ACCESS HEPATITIS C CHECK TEST SYSTEM
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Pwn Health Chicago, LLC
- Date received
- 2011-08-01
- Decision date
- 2011-08-31
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- New York, NY
- Statement
- NEW SUPPLIER FOR THE BARRIER POUCH COMPONENT OF THE DEVICE.
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