FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTECH L.D.X. LEVEL 1 CONTROL
K Number: K904784
·
Decision Dec 18, 1990
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
20
Review Days
57
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Basic Information
- Device Name
- CHOLESTECH L.D.X. LEVEL 1 CONTROL
- K Number
- K904784
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cholestech Corp.
- Date Received
- October 22, 1990
- Decision Date
- December 18, 1990
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 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 |
| 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 |