PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (V5191GUS)
FDA premarket approval P970054/S012 · decided 2017-01-19
Approval details
- PMA number
- P970054
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY (V5191GUS)
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Applicant
- Diasorin
- Date received
- 2016-12-22
- Decision date
- 2017-01-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MYL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Addition of new instrumentation for in-process QC and final kit release testing.
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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 |