PMA P790019S017

Device: IMX HAVAB -M (LIST NUMBER 2263)
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S017
Product code: LOL
Decision date: 2003-11-06
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: DISCONTINUE THE USE OF REFERENCE PANEL 4 AND ELIMINATE ALL ASSOCIATED VALIDITY AND ACCEPTANCE CRITERIA FROM BOTH THE INCOMING ALKALINE PHOSPHATASE AND THE IMX HAVAB-M CONJUGATE CONCENTRATE TESTING.

Current openFDA PMA Record#

Device: IMX HAVAB -M (LIST NUMBER 2263)
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S017
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2003-11-06
Decision code: OK30
Date received: 2003-10-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: DISCONTINUE THE USE OF REFERENCE PANEL 4 AND ELIMINATE ALL ASSOCIATED VALIDITY AND ACCEPTANCE CRITERIA FROM BOTH THE INCOMING ALKALINE PHOSPHATASE AND THE IMX HAVAB-M CONJUGATE CONCENTRATE TESTING.