AB -HAVK
FDA premarket approval P890019 · decided 1990-07-13
Approval details
- PMA number
- P890019
- Trade name
- AB -HAVK
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Diasorin
- Date received
- 1989-03-15
- Decision date
- 1990-07-13
- Days to decision
- 485 days
- Decision code
- APRL
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
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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 |