PMA P120012S018
- Device
- Abbott RealTime HCV GT II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S018
- Product code
- OBF
- Decision date
- 2019-05-15
- Classification
- Assay, Genotyping, Hepatitis C Virus
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- Implement additional QC to device accessory kits.
Current openFDA PMA Record#
- Device
- Abbott RealTime HCV GT II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S018
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2019-05-15
- Decision code
- OK30
- Date received
- 2019-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement additional QC to device accessory kits.