PMA P790019S019

Device: ABBOTT HAVAB -M EIA
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S019
Product code: LOL
Decision date: 2005-05-25
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: APPROVAL FOR CHANGE IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, OR OTHERWISE PROVIDE ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH, OR RELIABILITY OF THE ABBOTT HAVAB -M EIA ASSAY.

Current openFDA PMA Record#

Device: ABBOTT HAVAB -M EIA
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S019
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2005-05-25
Decision code: APPR
Date received: 2005-04-25
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR CHANGE IN QUALITY CONTROLS THAT ADD A NEW SPECIFICATION, OR OTHERWISE PROVIDE ADDITIONAL ASSURANCE OF PURITY, IDENTITY, STRENGTH, OR RELIABILITY OF THE ABBOTT HAVAB -M EIA ASSAY.