OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
FDA 510(k) clearance K963139 · decided 1997-02-06
Clearance details
- K-number
- K963139
- Device name
- OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-12
- Decision date
- 1997-02-06
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- DDD
- Device class
- 2
- Regulation number
- 866.5880
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter l recall (Z-0309-2024) | Beckman Coulter Biomedical Division | 2023-11-16 |