HOME ACCESS HEPATITIS C CHECK TEST SERVICE
FDA premarket approval P980046/S006 · decided 2003-09-08
Approval details
- PMA number
- P980046
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HOME ACCESS HEPATITIS C CHECK TEST SERVICE
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Pwn Health Chicago, LLC
- Date received
- 2003-05-28
- Decision date
- 2003-09-08
- Days to decision
- 103 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 FITZCO, INC., SPRING PARK, MINNESOTA.
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