RANDOX DIRECT LDL CHOLESTEROL
FDA 510(k) clearance K982529 · decided 1998-09-11
Clearance details
- K-number
- K982529
- Device name
- RANDOX DIRECT LDL CHOLESTEROL
- Applicant
- Randox Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-20
- Decision date
- 1998-09-11
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- MRR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Crumlin, Co. Antrim, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination o recall (Z-1268-2023) | Siemens Healthcare Diagnostics, Inc. | 2023-08-29 |