Cholestech Corp. - FDA 510(k) Cleared Devices
Recent clearances: CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP), CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST), CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cholestech Corp. Chemistry ✕
20 devices
Cleared
Jun 18, 2004
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
Chemistry
106d
Cleared
Sep 05, 2003
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
Chemistry
66d
Cleared
Sep 09, 1999
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
Chemistry
104d
Cleared
Jul 24, 1997
CHOLESTECH BUN/CREATININE TEST SYSTEM
Chemistry
55d
Cleared
Nov 24, 1995
CHOLESTECH LDX SYSTEM
Chemistry
66d
Cleared
Feb 22, 1995
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
Chemistry
99d
Cleared
Feb 22, 1995
TOTAL CHOLESTEROL CASSETTE
Chemistry
99d
Cleared
Feb 22, 1995
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
Chemistry
99d
Cleared
Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL
Chemistry
99d
Cleared
Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL
Chemistry
99d
Cleared
Nov 09, 1993
CHOLESTECH L.D.X. SYSTEM
Chemistry
158d
Cleared
Jun 24, 1992
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
Chemistry
22d