OLYMPUS CHOLESTEROL REAGENT
FDA 510(k) clearance K925603 · decided 1993-02-08
Clearance details
- K-number
- K925603
- Device name
- OLYMPUS CHOLESTEROL REAGENT
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-05
- Decision date
- 1993-02-08
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16 recall (Z-1025-2015) | Beckman Coulter Inc. | 2015-01-28 |