CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
FDA 510(k) clearance K922612 · decided 1992-06-24
Clearance details
- K-number
- K922612
- Device name
- CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
- Applicant
- Cholestech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-02
- Decision date
- 1992-06-24
- Days to decision
- 22 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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|---|
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| CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (K151545) | Polymer Technology Systems, Inc. | 2016-12-22 |
| Cholesterol (K150654) | Randox Laboratories, Ltd. | 2015-09-29 |
| AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (K132031) | Axis-Shield Poc AS | 2014-03-21 |
| PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (K130200) | Abaxis, Inc. | 2013-02-15 |
| ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K122757) | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-10-05 |
Recalls involving this device
No recalls on record reference this clearance.