PMA P090008S002
- Device
- ELECSYS ANTI-HCV IMMUNOASSAY
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P090008
- Supplement
- S002
- Product code
- MZO
- Decision date
- 2011-05-04
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT COMMON TO ALL DEVICES.
Current openFDA PMA Record#
- Device
- ELECSYS ANTI-HCV IMMUNOASSAY
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P090008
- Supplement
- S002
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-05-04
- Decision code
- OK30
- Date received
- 2011-04-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT COMMON TO ALL DEVICES.