Panels › Clinical Chemistry › Product code CHH · Class 1
Enzymatic Esterase--Oxidase, Cholesterol
Regulation 862.1175
1510(k)s in 12 months (230 all time)
1recalls in 12 months (23 all time)
19recalls that name a 510(k)
Top companies in CHH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 1997 | K971345 | CHOL OR CHOLESTEROL Carolina Liquid Chemistries Corp. | CHH |
| Sep 27, 1996 | K962890 | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) Trace Scientific , Ltd. | CHH |
| May 2, 1996 | K960377 | ENA-C-T TOTAL CHOLESTEROL TEST Actimed Laboratories, Inc. | CHH |
| Mar 6, 1996 | K944458 | ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST Boehringer Mannheim Corp. | CHH |
| Aug 23, 1995 | K946161 | DMA TOTAL CHOLESTEROL PROCEDURE Data Medical Associates, Inc. | CHH |
| Jul 20, 1995 | K952127 | BOEHRINGER MANNHEIM CHOLESTEROL ASSAY Boehringer Mannheim Corp. | CHH |
| Apr 13, 1995 | K950164 | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR Abaxis, Inc. | CHH |
| Mar 21, 1995 | K943599 | CHEM TRAK ACCUMETER Chemtrak, Inc. | CHH |
| Feb 22, 1995 | K946067 | TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL Cholestech Corp. | CHH |
| Feb 22, 1995 | K946066 | TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL Cholestech Corp. | CHH |
| Feb 22, 1995 | K946065 | TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL Cholestech Corp. | CHH |
| Feb 22, 1995 | K946064 | TOTAL CHOLESTEROL CASSETTE Cholestech Corp. | CHH |
| Feb 22, 1995 | K946063 | TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL Cholestech Corp. | CHH |
| Jan 27, 1995 | K943027 | CHOLESTEROL QVET Prisma Systems | CHH |
| Oct 31, 1994 | K941573 | ROCHE REAGENT Roche Diagnostic Systems, Inc. | CHH |
| Jan 10, 1994 | K923504 | CHOLESTEROL ENZYMATIC ENDPOINT Randox Laboratories, Ltd., IR | CHH |
| Dec 16, 1993 | K935136 | CHOLESTEROL (CHOL) TEST ITEM NO. 65410 Em Diagnostic Systems, Inc. | CHH |
| Oct 28, 1993 | K934046 | BECKMAN CHOLESTEROL REAGENT Beckman-Diagnostic Systems Group | CHH |
| Mar 2, 1993 | K914432 | ACCUMETER(R) CHOLESTEROL SELF-TEST Chemtrak, Inc. | CHH |
| Feb 8, 1993 | K925603 | OLYMPUS CHOLESTEROL REAGENT Olympus Corp. | CHH |
| Jan 28, 1993 | K924508 | CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 Em Diagnostic Systems, Inc. | CHH |
| Nov 18, 1992 | K922231 | OLYMPUS CHOLESTEROL REAGENT Olympus Corp. | CHH |
| Oct 26, 1992 | K923733 | CHOLESTEROL TEST Em Diagnostic Systems, Inc. | CHH |
| Sep 9, 1992 | K923128 | KING DIAGNOSTICS CHOLESTEROL REAGENT King Diagnostics, Inc. | CHH |
| Jun 24, 1992 | K922612 | CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE Cholestech Corp. | CHH |
| Jan 30, 1992 | K914160 | CHOLESTEROL REGEANT SET Tech Intl. Co. | CHH |
| Dec 18, 1991 | K913565 | ABBOTT QUICKSTART CHOLESTEROL TEST Em Diagnostic Systems, Inc. | CHH |
| Oct 30, 1991 | K914469 | CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL Cholestech Corp. | CHH |
| Sep 27, 1991 | K912499 | KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST King Diagnostics, Inc. | CHH |
| Aug 28, 1991 | K912212 | PROACT CHOLESTEROL SYSTEMS Boehringer Mannheim Corp. | CHH |
| Aug 16, 1991 | K911692 | ENZYMATICS, INC., TOTAL CHOLESTEROL TEST Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | CHH |
| Jul 30, 1991 | K912136 | CHOLESTECH LIPID MONITORING SYS. Cholestech Corp. | CHH |
| May 15, 1991 | K911578 | CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION Cholestech Corp. | CHH |
| Mar 19, 1991 | K905405 | CHEMTRAK ACCUMETER CHOLESTEROL TEST Chemtrak, Inc. | CHH |
| Mar 11, 1991 | K904031 | CHEMA CHOL CHOLESTEROL SYSTEM Texas Intl. Laboratories, Inc. | CHH |
| Mar 6, 1991 | K905648 | CRP LIPID REAGENT TEST PACK Cirrus Diagnostics, Inc. | CHH |
| Feb 26, 1991 | K910240 | CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST Crystal Diagnostics, Inc. | CHH |
| Feb 26, 1991 | K905145 | ECLIPSE ICA CHOLESTEROL Biotope, Inc. | CHH |
| Dec 26, 1990 | K903126 | CHOLESTAT(TM) WHOLE BLOOD CHOLESTEROL TEST Crystal Diagnostics, Inc. | CHH |
| Oct 1, 1990 | K903015 | SYNERMED CHOLESTEROL REAGENT KIT Synermed, Inc., CA | CHH |
| Sep 25, 1990 | K902678 | LIQUID STABLE CHOLESTEROL REAGENT KIT Trace Scientific , Ltd., AU | CHH |
| Aug 9, 1990 | K902098 | CHOLESTEROL (RATE) REAGENT Sigma Chemical Co. | CHH |
| Jul 24, 1990 | K901900 | L.D.X LIPID MONITORING SYSTEM Cholestech Corp. | CHH |
| Jun 12, 1990 | K896467 | SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM Medisense, Inc. | CHH |
| Mar 29, 1990 | K900850 | EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 Em Diagnostic Systems, Inc. | CHH |
| Mar 29, 1990 | K897162 | COULTER CHOLESTEROL REAGENT Coulter Electronics, Inc. | CHH |
| Mar 6, 1990 | K897036 | IMMUNOTECH CHOLESTEROL TEST Immunotech Corp. | CHH |
| Feb 16, 1990 | K896239 | COBAS READY CHOLESTEROL REAGENT Roche Diagnostic Systems, Inc. | CHH |
| Feb 16, 1990 | K895951 | CHOLESTEROL TEST KIT Elite Technology, Inc., CA | CHH |
| Dec 12, 1989 | K896073 | CHOLESTEROL, UNIVERSAL ET Enzyme Technology, Inc. | CHH |
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