DIASORIN ETI-AB-HAVK PLUS
FDA premarket approval P890019/S011 · decided 2005-06-22
Approval details
- PMA number
- P890019
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIASORIN ETI-AB-HAVK PLUS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- Diasorin
- Date received
- 2005-06-03
- Decision date
- 2005-06-22
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- CHANGE IN THE TESTING PARAMETERS USED TO DETERMINE SPECIFIC ATTRIBUTES OF RAW MATERIALS FOR THE 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 |