RANDOX IGE
FDA 510(k) clearance K010855 · decided 2001-05-15
Clearance details
- K-number
- K010855
- Device name
- RANDOX IGE
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-22
- Decision date
- 2001-05-15
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- DGC
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Crumlin, Co. Antrim, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IgE Calibrator Series recall (Z-0050-2017) | Randox Laboratories Ltd. | 2016-10-06 |