PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED
FDA 510(k) clearance K942458 · decided 1995-03-13
Clearance details
- K-number
- K942458
- Device name
- PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-05-24
- Decision date
- 1995-03-13
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Crumlin, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber g recall (Z-2768-2015) | MedtestDx, Inc. | 2015-09-15 |