L.D.X LIPID MONITORING SYSTEM
FDA 510(k) clearance K901900 · decided 1990-07-24
Clearance details
- K-number
- K901900
- Device name
- L.D.X LIPID MONITORING SYSTEM
- Applicant
- Cholestech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-27
- Decision date
- 1990-07-24
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic. recall (Z-0964-2012) | Alere San Diego | 2012-02-06 |