HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS
FDA premarket approval P890014/S003 · decided 2001-02-02
Approval details
- PMA number
- P890014
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HA-IGMK RIA ASSAY/ETI-HA-IGMK PLUS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- DiaSorin, Inc.
- Date received
- 2000-10-05
- Decision date
- 2001-02-02
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- 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.
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