PMA P780012S014
- Device
- AXSYM HAVAB 2.0
- Applicant
- Abbott Laboratories
- PMA number
- P780012
- Supplement
- S014
- Product code
- LOL
- Decision date
- 2004-07-30
- 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
- AXSYM HAVAB 2.0
- Applicant
- Abbott Laboratories
- PMA number
- P780012
- Supplement
- S014
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 2004-07-30
- Decision code
- APPR
- Date received
- 2004-07-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS.