DIASORIN ETI-AB-HAVK PLUS ASSAY
FDA premarket approval P890019/S009 · decided 2004-02-20
Approval details
- PMA number
- P890019
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Trade name
- DIASORIN ETI-AB-HAVK PLUS ASSAY
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Diasorin
- Date received
- 2004-01-30
- Decision date
- 2004-02-20
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT: THE SUPPLEMENT CONTAINS A REVISION IN THE ASSAY PACKAGE INSERT THAT STATES "ALL LOTS OF INCUBATION BUFFER ARE INTERCHANGEABLE BETWEEN ETI-EBK PLUS, ETI-AB-EBK PLUS, ETI-AB-HAVK PLUS."
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS (K130321) | Diasorin | 2013-04-09 |