PMA P080026S022
- Device
- RealTime HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P080026
- Supplement
- S022
- Product code
- MKT
- Decision date
- 2019-05-15
- Classification
- Hepatitis Viral B Dna Detection
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Implement additional QC to device accessory kits.
Current openFDA PMA Record#
- Device
- RealTime HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P080026
- Supplement
- S022
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- 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.