FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K Number: K904082
·
Decision Dec 26, 1990
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
20
Review Days
112
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Basic Information
- Device Name
- CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
- K Number
- K904082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cholestech Corp.
- Date Received
- September 5, 1990
- Decision Date
- December 26, 1990
- Product Code
- CGA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | Jul 24, 1997 | Substantially Equivalent |
| K954778 | CHOLESTECH LDX SYSTEM | Nov 24, 1995 | Substantially Equivalent |
| K946067 | TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL | Feb 22, 1995 | Substantially Equivalent |
| K946063 | TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL | Feb 22, 1995 | Substantially Equivalent |
| K946065 | TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL | Feb 22, 1995 | Substantially Equivalent |
| K946064 | TOTAL CHOLESTEROL CASSETTE | Feb 22, 1995 | Substantially Equivalent |
| K946066 | TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL | Feb 22, 1995 | Substantially Equivalent |