FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTECH LDX SYSTEM
K Number: K954778
·
Decision Nov 24, 1995
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
20
Review Days
66
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Basic Information
- Device Name
- CHOLESTECH LDX SYSTEM
- K Number
- K954778
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cholestech Corp.
- Date Received
- September 19, 1995
- Decision Date
- November 24, 1995
- Product Code
- LBS
- 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 |
|---|---|---|---|
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
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Other Clearances by Cholestech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | Jun 18, 2004 | Substantially Equivalent |
| K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | Sep 5, 2003 | Substantially Equivalent |
| K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | Sep 9, 1999 | Substantially Equivalent |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | Jul 24, 1997 | 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 |
| K932727 | CHOLESTECH L.D.X. SYSTEM | Nov 9, 1993 | Substantially Equivalent |