RANDOX LIQUID PROTEIN CALIBRATOR
FDA 510(k) clearance K061056 · decided 2006-07-20
Clearance details
- K-number
- K061056
- Device name
- RANDOX LIQUID PROTEIN CALIBRATOR
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-17
- Decision date
- 2006-07-20
- Days to decision
- 94 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 |
|---|---|---|
| Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox recall (Z-1328-2024) | Randox Laboratories Ltd. | 2024-03-20 |
| Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the ca recall (Z-2448-2023) | Randox Laboratories Ltd. | 2023-08-23 |