RX IMOLA
FDA 510(k) clearance K052914 · decided 2006-03-31
Clearance details
- K-number
- K052914
- Device name
- RX IMOLA
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-14
- Decision date
- 2006-03-31
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- CEM
- Device class
- 2
- Regulation number
- 862.1600
- 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 |
|---|---|---|
| RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished) recall (Z-0200-2024) | Randox Laboratories Ltd. | 2023-10-31 |