RANDOX LIPOPROTEIN
FDA 510(k) clearance K011568 · decided 2001-09-28
Clearance details
- K-number
- K011568
- Device name
- RANDOX LIPOPROTEIN
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-21
- Decision date
- 2001-09-28
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- JIS
- 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 |
|---|---|---|
| Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on recall (Z-1017-2025) | Randox Laboratories, Limited | 2025-01-23 |
| Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on recall (Z-1018-2025) | Randox Laboratories, Limited | 2025-01-23 |