RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
FDA 510(k) clearance K140522 · decided 2014-05-22
Clearance details
- K-number
- K140522
- Device name
- RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
- Applicant
- Randox Laboratories Limited
- Decision
- Substantially Equivalent
- Date received
- 2014-03-04
- Decision date
- 2014-05-22
- Days to decision
- 79 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 |
|---|---|---|
| Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material t recall (Z-2021-2023) | Randox Laboratories Ltd. | 2023-06-28 |
| Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control recall (Z-2022-2023) | Randox Laboratories Ltd. | 2023-06-28 |