CHH · Class I · 21 CFR 862.1175

FDA Product Code CHH: Enzymatic Esterase--oxidase, Cholesterol

Leading manufacturers include Cholestech Corp., Em Diagnostic Systems, Inc. and Beckman Instruments, Inc..

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
25–48 of 230
Cleared Jan 24, 2003
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
K023642
Abaxis, Inc.
Chemistry · 86d
Cleared Nov 15, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K023558
Polymer Technology Systems, Inc.
Chemistry · 23d
Cleared Sep 24, 2002
PTS PANELS LIPID PANEL TEST STRIPS
K022898
Polymer Technology Systems, Inc.
Chemistry · 21d
Cleared Oct 22, 2001
BIOSCANNER PLUS
K013173
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Sep 26, 2001
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K011970
Biosafe Laboratories, Inc.
Chemistry · 93d
Cleared Jul 24, 2000
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
K001032
Otsuka Pharmaceutical Co., Ltd.
Chemistry · 116d
Cleared Jul 21, 2000
RESOLUTION CHOLESTEROL MONITOR
K000610
Lifestream Technologies, Inc.
Chemistry · 149d
Cleared May 02, 2000
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
K000900
Elan Holdings, Inc.
Chemistry · 42d
Cleared Dec 20, 1999
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
K993096
Lifestream Technologies, Inc.
Chemistry · 206d
Cleared Sep 13, 1999
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
K992803
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Aug 20, 1999
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
K991083
Otsuka Pharmaceutical Co., Ltd.
Chemistry · 142d
Cleared Aug 20, 1999
CHOLESITE TEST SYSTEM
K992132
Gds Technology, LLC
Chemistry · 58d
Cleared Jun 24, 1999
MTM BIOSCANNER C TEST STRIPS
K990688
Polymer Technology Systems, Inc.
Chemistry · 119d
Cleared Oct 01, 1998
CHOLESTRON PRO II CHOLESTEROL TEST
K981345
Lifestream Diagnostics, Inc.
Chemistry · 170d
Cleared Aug 19, 1998
HICHEM CHOLESTEROL REAGENT KIT
K982469
Elan Pharma, Inc.
Chemistry · 35d
Cleared Aug 03, 1998
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
K981181
Actimed Laboratories, Inc.
Chemistry · 124d
Cleared Jul 24, 1998
CARESIDE ANALYZER
K982118
Exigent Diagnostics, Inc.
Chemistry · 51d
Cleared Jul 22, 1998
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
K981493
Polymer Technology Systems, Inc.
Chemistry · 86d
Cleared Jun 29, 1998
CHOL
K981652
Abbott Laboratories
Chemistry · 49d
Cleared Jun 25, 1998
CHOL
K981476
Abbott Laboratories
Chemistry · 62d
Cleared Apr 21, 1998
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K980667
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284
Roche Diagnostic Systems, Inc.
Chemistry · 107d
Cleared Sep 24, 1997
CHOLESTEROL RAPID LIQUID REAGENT
K972853
Reagents Applications, Inc.
Chemistry · 89d
Cleared Jun 20, 1997
CHOLESTEROL REAGENT
K971072
Derma Media Lab., Inc.
Chemistry · 88d