PMA P200013S006
- Device
- Alinity m HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S006
- Product code
- MKT
- Decision date
- 2022-03-14
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Extend the expiration date of a critical raw material.
Current openFDA PMA Record#
- Device
- Alinity m HBV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P200013
- Supplement
- S006
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2022-03-14
- Decision code
- OK30
- Date received
- 2022-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extend the expiration date of a critical raw material.