PMA P150014S050
- Device
- Roche cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S050
- Product code
- MKT
- Decision date
- 2024-07-01
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- to change manufacturing processes
Current openFDA PMA Record#
- Device
- Roche cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S050
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2024-07-01
- Decision code
- OK30
- Date received
- 2024-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to change manufacturing processes