HEPATITIS C CHECK TESTING SERVICE
FDA premarket approval P980046/S002 · decided 2000-04-12
Approval details
- PMA number
- P980046
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Trade name
- HEPATITIS C CHECK TESTING SERVICE
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Pwn Health Chicago, LLC
- Date received
- 2000-03-23
- Decision date
- 2000-04-12
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- New York, NY
- Statement
- As a final packaging option, the outer packaging of the Hepatitis C Check product may be assembled in a Softpak package or the currently approved paperboard packaging when shipped directly to clients.
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