PMA P980046S006
- Device
- HOME ACCESS HEPATITIS C CHECK TEST SERVICE
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S006
- Product code
- MZO
- Decision date
- 2003-09-08
- 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 FITZCO, INC., SPRING PARK, MINNESOTA.
Current openFDA PMA Record#
- Device
- HOME ACCESS HEPATITIS C CHECK TEST SERVICE
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S006
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2003-09-08
- Decision code
- APPR
- Date received
- 2003-05-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT FITZCO, INC., SPRING PARK, MINNESOTA.