PMA P980046S002
- Device
- HEPATITIS C CHECK TESTING SERVICE
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S002
- Product code
- MZO
- Decision date
- 2000-04-12
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order 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.
Current openFDA PMA Record#
- Device
- HEPATITIS C CHECK TESTING SERVICE
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S002
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2000-04-12
- Decision code
- OK30
- Date received
- 2000-03-23
- Supplement type
- 30-Day Notice
- Approval order 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.