Cholestech Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K040579CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)June 18, 2004
K032027CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)September 5, 2003
K991834CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772September 9, 1999
K972012CHOLESTECH BUN/CREATININE TEST SYSTEMJuly 24, 1997
K954778CHOLESTECH LDX SYSTEMNovember 24, 1995
K946063TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANELFebruary 22, 1995
K946066TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANELFebruary 22, 1995
K946064TOTAL CHOLESTEROL CASSETTEFebruary 22, 1995
K946067TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANELFebruary 22, 1995
K946065TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANELFebruary 22, 1995
K932727CHOLESTECH L.D.X. SYSTEMNovember 9, 1993
K922612CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTEJune 24, 1992
K914469CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANELOctober 30, 1991
K914033CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TESTSeptember 27, 1991
K912136CHOLESTECH LIPID MONITORING SYS.July 30, 1991
K911578CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATIONMay 15, 1991
K905296CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROLDecember 26, 1990
K904082CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TESTDecember 26, 1990
K904784CHOLESTECH L.D.X. LEVEL 1 CONTROLDecember 18, 1990
K901900L.D.X LIPID MONITORING SYSTEMJuly 24, 1990