ETI-CORE-IGMK PLUS assay
FDA premarket approval P990044/S027 · decided 2019-09-27
Approval details
- PMA number
- P990044
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETI-CORE-IGMK PLUS assay
- Applicant
- DiaSorin, Inc.
- Date received
- 2019-08-28
- Decision date
- 2019-09-27
- Days to decision
- 30 days
- Decision code
- OK30
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Chromatography column cleaning procedure modifications.
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510(k) clearances by this applicant
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|---|---|---|
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| LIAISON Anti-HAV; LIAISON XS (K223403) | DiaSorin, Inc. | 2022-12-09 |
| LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (K213858) | DiaSorin, Inc. | 2022-07-26 |
| LIAISON MeMed BV, LIAISON MeMed BV Control Set (K213936) | DiaSorin, Inc. | 2022-07-14 |
| LIAISON Ferritin (K193650) | DiaSorin, Inc. | 2021-09-14 |
| LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (K202573) | DiaSorin, Inc. | 2021-02-18 |