PMA P980046S008
- Device
- HOME ACCESS HEPATITIS C CHECK TEST SYSTEM
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S008
- Product code
- MZO
- Decision date
- 2011-08-31
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- NEW SUPPLIER FOR THE BARRIER POUCH COMPONENT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- HOME ACCESS HEPATITIS C CHECK TEST SYSTEM
- Applicant
- Pwn Health Chicago, LLC
- PMA number
- P980046
- Supplement
- S008
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-08-31
- Decision code
- OK30
- Date received
- 2011-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW SUPPLIER FOR THE BARRIER POUCH COMPONENT OF THE DEVICE.