PMA P790019S015
- Device
- IMX HAVAB-M
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S015
- Product code
- LOL
- Decision date
- 2002-09-05
- Classification
- Microbiology
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Approval order statement
- APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.
Current openFDA PMA Record#
- Device
- IMX HAVAB-M
- Applicant
- Abbott Laboratories
- PMA number
- P790019
- Supplement
- S015
- Product code
- LOL
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Decision date
- 2002-09-05
- Decision code
- APPR
- Date received
- 2002-03-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD A QUALITY CONTROL TEST WHICH WILL BE PERFORMED AFTER THE REAGENT PACK IS PACKAGED.