PMA P190025S001
- Device
- Alinity m HCV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P190025
- Supplement
- S001
- Product code
- MZP
- Decision date
- 2020-05-06
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- Instrument component change by a supplier.
Current openFDA PMA Record#
- Device
- Alinity m HCV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P190025
- Supplement
- S001
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2020-05-06
- Decision code
- OK30
- Date received
- 2020-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Instrument component change by a supplier.