ETI-HA-IGMK PLUS KIT
FDA premarket approval P890014/S008 · decided 2005-12-14
Approval details
- PMA number
- P890014
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ETI-HA-IGMK PLUS KIT
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- DiaSorin, Inc.
- Date received
- 2005-07-20
- Decision date
- 2005-12-14
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR CHANGE TO THE ASSAY CUTOFF CALCULATION THAT IS DESIGNED TO REDUCE THE NUMBER OF LOW LEVEL, NON-CLINICALLY RELEVANT POSITIVE RESULTS REPORTED BY THE ETI-HA-IGMK PLUS ASSAY.
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