PMA P980046S004
- Device
- HOME ACCESS HEPATITIS C CHECK TEST
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S004
- Product code
- MZO
- Decision date
- 2001-03-21
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT HOME ACCESS HEALTH CORPORATION, HOFFMAN ESTATES, ILLINOIS.
Current openFDA PMA Record#
- Device
- HOME ACCESS HEPATITIS C CHECK TEST
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S004
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2001-03-21
- Decision code
- APPR
- Date received
- 2001-02-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT HOME ACCESS HEALTH CORPORATION, HOFFMAN ESTATES, ILLINOIS.