PMA P890014S003

Device: HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S003
Product code: LOL
Decision date: 2001-02-02
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: APPROVAL FOR A CHANGE IN THE STORAGE CONDITIONS AND PURIFICATION PROCESS OF SOME COMPONENTS OF THE HA-IGMK RIA DEVICE, AND THE ETI-HA-IGMK PLUS DEVICE.

Current openFDA PMA Record#

Device: HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS
Applicant: DiaSorin, Inc.
PMA number: P890014
Supplement: S003
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2001-02-02
Decision code: APPR
Date received: 2000-10-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE IN THE STORAGE CONDITIONS AND PURIFICATION PROCESS OF SOME COMPONENTS OF THE HA-IGMK RIA DEVICE, AND THE ETI-HA-IGMK PLUS DEVICE.