HOME ACCESS HEPATITIS C CHECK TEST
FDA premarket approval P980046/S004 · decided 2001-03-21
Approval details
- PMA number
- P980046
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HOME ACCESS HEPATITIS C CHECK TEST
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Pwn Health Chicago, LLC
- Date received
- 2001-02-23
- Decision date
- 2001-03-21
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT HOME ACCESS HEALTH CORPORATION, HOFFMAN ESTATES, ILLINOIS.
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