AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS
FDA premarket approval P890019/S006 · decided 2001-02-02
Approval details
- PMA number
- P890019
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AB-HAVK RIA ASSAY/ETI-AB-HAVK PLUS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Diasorin
- 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 PURIFICATION PROCESS AND STORAGE CONDITIONS OF COMPONENTS OF THE AB-HAVK RIA DEVICE AND THE ETI-AB-HAVK PLUS DEVICE.
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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 |