PMA P790019
- Device
- ABBOTT IMX HAVAB-M LIST 2263
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S010
- Product code
- LOL
- Decision date
- 2005-10-06
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Approval order statement
- CHANGES IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, IMPLEMENTED TO IMPROVE MANUFACTURABILITY WITHOUT COMPROMISING PRODUCT PERFORMANCE.
Current openFDA PMA Record
- Device
- ABBOTT IMX HAVAB-M LIST 2263
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S020
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 2005-10-06
- Decision code
- OK30
- Date received
- 2005-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, IMPLEMENTED TO IMPROVE MANUFACTURABILITY WITHOUT COMPROMISING PRODUCT PERFORMANCE.