ETI-AB-HAVK PLUS
FDA premarket approval P890019/S012 · decided 2005-12-12
Approval details
- PMA number
- P890019
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETI-AB-HAVK PLUS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Diasorin
- Date received
- 2005-11-14
- Decision date
- 2005-12-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR CHANGE IN THE MANUFACTURING PROCESS FOR THE NEUTRALIZING SOLUTION (HAV REAGENT).
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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 |