BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
FDA premarket approval P970054/S001 · decided 2003-01-09
Approval details
- PMA number
- P970054
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Trade name
- BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
- Generic name
- ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG
- Applicant
- Diasorin
- Date received
- 2002-11-15
- Decision date
- 2003-01-09
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- MYL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR ADDING A QUALITY ASSURANCE INSPECTION STEP.
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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 |