FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
K Number: K946065
·
Decision Feb 22, 1995
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
20
Review Days
99
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Basic Information
- Device Name
- TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
- K Number
- K946065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cholestech Corp.
- Date Received
- November 15, 1994
- Decision Date
- February 22, 1995
- Product Code
- CHH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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| K946063 | TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL | Feb 22, 1995 | Substantially Equivalent |
| K946064 | TOTAL CHOLESTEROL CASSETTE | Feb 22, 1995 | Substantially Equivalent |
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| K932727 | CHOLESTECH L.D.X. SYSTEM | Nov 9, 1993 | Substantially Equivalent |