PMA P150015S038
- Device
- cobas HCV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150015
- Supplement
- S038
- Product code
- MZP
- Decision date
- 2020-05-14
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- Additional of a second supplier source for a manufacturing component.
Current openFDA PMA Record#
- Device
- cobas HCV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150015
- Supplement
- S038
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2020-05-14
- Decision code
- OK30
- Date received
- 2020-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional of a second supplier source for a manufacturing component.