Medical Device Manufacturer · US , Hayward , CA

Cholestech Corp.

20 submissions · 20 cleared · Since 1990
20
Total
20
Cleared
0
Denied

Cholestech Corp. — FDA 510(k) Submissions

Cholestech Corp. has submitted 20 FDA 510(k) premarket notifications since 1990, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzymatic Esterase--oxidase, Cholesterol, Glucose Oxidase, Glucose, Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl, Urease, Photometric, Urea Nitrogen, Hydrazone Colorimetry, Alt/sgpt . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
K040579 · DCK C-reactive Protein,... · Chemistry
Jun 2004 106d
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
K032027 · CIS Hydrazone Colorimetry,... · Chemistry
Sep 2003 66d
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
K991834 · CKD Hydrazone Colorimetry,... · Chemistry
Sep 1999 104d
CHOLESTECH BUN/CREATININE TEST SYSTEM
K972012 · CDN Urease, Photometric, Urea... · Chemistry
Jul 1997 55d
CHOLESTECH LDX SYSTEM
K954778 · LBS Ldl & Vldl Precipitation,... · Chemistry
Nov 1995 66d
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
K946063 · CHH Enzymatic... · Chemistry
Feb 1995 99d
TOTAL CHOLESTEROL CASSETTE
K946064 · CHH Enzymatic... · Chemistry
Feb 1995 99d
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
K946065 · CHH Enzymatic... · Chemistry
Feb 1995 99d
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL
K946066 · CHH Enzymatic... · Chemistry
Feb 1995 99d
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL
K946067 · CHH Enzymatic... · Chemistry
Feb 1995 99d
CHOLESTECH L.D.X. SYSTEM
K932727 · CGA Glucose Oxidase, Glucose · Chemistry
Nov 1993 158d
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
K922612 · CHH Enzymatic... · Chemistry
Jun 1992 22d
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
K914469 · CHH Enzymatic... · Chemistry
Oct 1991 23d
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST
K914033 · JGY Colorimetric Method,... · Chemistry
Sep 1991 17d
CHOLESTECH LIPID MONITORING SYS.
K912136 · CHH Enzymatic... · Chemistry
Jul 1991 77d
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
K911578 · CHH Enzymatic... · Chemistry
May 1991 49d
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K904082 · CGA Glucose Oxidase, Glucose · Chemistry
Dec 1990 112d
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
K905296 · LBS Ldl & Vldl Precipitation,... · Chemistry
Dec 1990 29d
CHOLESTECH L.D.X. LEVEL 1 CONTROL
K904784 · JJY Multi-analyte Controls,... · Chemistry
Dec 1990 57d
L.D.X LIPID MONITORING SYSTEM
K901900 · CHH Enzymatic... · Chemistry
Jul 1990 88d
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