RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
FDA 510(k) clearance K110904 · decided 2011-09-30
Clearance details
- K-number
- K110904
- Device name
- RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-31
- Decision date
- 2011-09-30
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- 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 |
|---|---|---|
| Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality recall (Z-2446-2023) | Randox Laboratories Ltd. | 2023-08-23 |
| Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In- recall (Z-2167-2017) | Randox Laboratories | 2017-05-26 |