PMA P980046S007
- Device
- HEPATITS C CHECK TEST SYSTEM
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S007
- Product code
- MZO
- Decision date
- 2004-12-10
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE TO A SUPPLIER OF A COMPONENT OF THE HEPATITIS C CHECK TEST SYSTEM.
Current openFDA PMA Record#
- Device
- HEPATITS C CHECK TEST SYSTEM
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S007
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2004-12-10
- Decision code
- OK30
- Date received
- 2004-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO A SUPPLIER OF A COMPONENT OF THE HEPATITIS C CHECK TEST SYSTEM.