PMA P200013S004
- Device
- Alinity m HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S004
- Product code
- MKT
- Decision date
- 2021-03-08
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Addition of alternative testing location for a device component.
Current openFDA PMA Record#
- Device
- Alinity m HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S004
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2021-03-08
- Decision code
- OK30
- Date received
- 2021-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternative testing location for a device component.