PMA P150014S035
- Device
- cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S035
- Product code
- MKT
- Decision date
- 2020-02-06
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Change of a suppliers manufacturing site for a critical component.
Current openFDA PMA Record#
- Device
- cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S035
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2020-02-06
- Decision code
- OK30
- Date received
- 2020-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of a suppliers manufacturing site for a critical component.