PMA P790019S018
- Device
- DEVICE: ABBOTT AXSYM HAVAB-M 2.0
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S018
- Product code
- LOL
- Decision date
- 2004-06-16
- Classification
- Microbiology
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Approval order statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- DEVICE: ABBOTT AXSYM HAVAB-M 2.0
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S018
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 2004-06-16
- Decision code
- APPR
- Date received
- 2004-05-21
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.