HOME ACCESS HEPATITIS C TEST SERVICE
FDA premarket approval P980046/S005 · decided 2002-12-06
Approval details
- PMA number
- P980046
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HOME ACCESS HEPATITIS C TEST SERVICE
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Pwn Health Chicago, LLC
- Date received
- 2002-10-24
- Decision date
- 2002-12-06
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR A REDUCTION OF A SUPPLEMENT TESTING RANGE (STR) FROM SPECIMENS WITH A SIGNAL-TO-CUTOFF VALUE FROM 5.0 TO 4.2.
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