Medical Device Manufacturer · US , Hayward , CA

Cholestech Corp. - FDA 510(k) Cleared Devices

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

Cholestech Corp. has 20 FDA 510(k) cleared chemistry devices. Based in Hayward, US.

Historical record: 20 cleared submissions from 1990 to 2004.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Cholestech Corp.

20 devices
1-20 of 20
Cleared Jun 18, 2004
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
K040579 · DCK
Chemistry · 106d
Cleared Sep 05, 2003
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
K032027 · CIS
Chemistry · 66d
Cleared Sep 09, 1999
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
K991834 · CKD
Chemistry · 104d
Cleared Jul 24, 1997
CHOLESTECH BUN/CREATININE TEST SYSTEM
K972012 · CDN
Chemistry · 55d
Cleared Nov 24, 1995
CHOLESTECH LDX SYSTEM
K954778 · LBS
Chemistry · 66d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
K946063 · CHH
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL CASSETTE
K946064 · CHH
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
K946065 · CHH
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL
K946066 · CHH
Chemistry · 99d
Cleared Feb 22, 1995
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL
K946067 · CHH
Chemistry · 99d
Cleared Nov 09, 1993
CHOLESTECH L.D.X. SYSTEM
K932727 · CGA
Chemistry · 158d
Cleared Jun 24, 1992
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE
K922612 · CHH
Chemistry · 22d
Cleared Oct 30, 1991
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
K914469 · CHH
Chemistry · 23d
Cleared Sep 27, 1991
CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST
K914033 · JGY
Chemistry · 17d
Cleared Jul 30, 1991
CHOLESTECH LIPID MONITORING SYS.
K912136 · CHH
Chemistry · 77d
Cleared May 15, 1991
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
K911578 · CHH
Chemistry · 49d
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K904082 · CGA
Chemistry · 112d
Cleared Dec 26, 1990
CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL
K905296 · LBS
Chemistry · 29d
Cleared Dec 18, 1990
CHOLESTECH L.D.X. LEVEL 1 CONTROL
K904784 · JJY
Chemistry · 57d
Cleared Jul 24, 1990
L.D.X LIPID MONITORING SYSTEM
K901900 · CHH
Chemistry · 88d
Filters
All20 Chemistry 20