PMA P890014S004

Device: ETI-HA-IGMK PLUS KIT
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S004
Product code: LOL
Decision date: 2002-11-08
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.

Current openFDA PMA Record#

Device: ETI-HA-IGMK PLUS KIT
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S004
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2002-11-08
Decision code: OK30
Date received: 2002-10-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.