RANDOX CALIBRATION SERUM
FDA 510(k) clearance K053153 · decided 2006-01-13
Clearance details
- K-number
- K053153
- Device name
- RANDOX CALIBRATION SERUM
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-10
- Decision date
- 2006-01-13
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Crumlin, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized h recall (Z-1759-2024) | Randox Laboratories Ltd. | 2024-05-03 |
| Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) H recall (Z-0751-2024) | Randox Laboratories Ltd. | 2024-01-18 |
| Calibration Serum Level 3 CAL2351 recall (Z-0752-2024) | Randox Laboratories Ltd. | 2024-01-18 |
| Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catal recall (Z-0753-2024) | Randox Laboratories Ltd. | 2024-01-18 |