FDA 510(k) Applications for Medical Device Product Code "CDT"
(Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)

FDA 510(k) Number Applicant Device Name Decision Date
K874187 ABBOTT LABORATORIES A-GENT TRIGLLYCERIDES GPO 01/21/1988
K771608 ABBOTT LABORATORIES A-GENT TRIGLYCERIDES 09/15/1977
K850031 ABBOTT LABORATORIES VISION TRIGLYCERIDES 02/04/1985
K852010 ALPKEM CORP. TGL REAGENT 05/30/1985
K890337 ALPKEM CORP. TRIGLYCERIDES - GPO REAGENT 03/09/1989
K840780 AMERICAN DADE TRIGLYCERIDES REAGENT 04/05/1984
K854366 AMERICAN MONITOR CORP. ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD 11/25/1985
K871301 AMERICAN MONITOR CORP. ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD 04/22/1987
K894310 AMERICAN RESEARCH PRODUCTS CO. AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730) 09/28/1989
K803297 AMRESCO, INC. LUQUIZYME TRIGLYCERIDE REAGENT SET 01/16/1981
K812838 ANCO MEDICAL REAGENTS & ASSOC. TRIGLYCERIDE REAGENT SET 12/03/1981
K842443 AXIOM, INC. AXIOM STABLE II TRIGLYCERIDES TEST 09/13/1984
K802136 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DELTA TEST TRIGLYCERIDES 10/10/1980
K864268 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ TRIGLYCERIDES 12/16/1986
K842891 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QCA TRIGLYCERIDES 08/22/1984
K864939 BECKMAN INSTRUMENTS, INC. BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT 12/31/1986
K915084 BECKMAN INSTRUMENTS, INC. BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT 01/28/1992
K761200 BECKMAN INSTRUMENTS, INC. ENZYMATIC TRIGLYCERIDES (END POINT) 12/21/1976
K781939 BECKMAN INSTRUMENTS, INC. REAGENT KIT, TRIGLYCERIDES 01/10/1979
K843552 BIO-RAD TRIGLYCERIDES GPO REAGENT 09/26/1984
K871122 BIOCHEMICAL TRADE, INC. TRIGLYCERIDES DETERMINATION 04/07/1987
K905601 BIOTOPE, INC. ECLIPSE ICA TRIGLYCERIDES 01/17/1991
K873160 BIOTROL, USA, INC. BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR 09/08/1987
K881702 BIOTROL, USA, INC. BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. 05/27/1988
K850667 BOEHRINGER MANNHEIM CORP. PERIDOCHROM TRIGLYCERIDES GPO 03/11/1985
K833082 BOEHRINGER MANNHEIM CORP. REAGENT SET TRIGLYCERIDES GPO 11/25/1983
K792234 BOEHRINGER MANNHEIM CORP. SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES 11/27/1979
K873049 BOEHRINGER MANNHEIM CORP. TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL 08/28/1987
K760713 BOEHRINGER MANNHEIM CORP. TRIGLYCERIDES TEST 11/29/1976
K861793 BOEHRINGER MANNHEIM CORP. TWIN TRIGLYCERIDES GPO/CHOLESTEROL 06/27/1986
K790773 CALBIOCHEM-BEHRING CORP. ENZYMATIC TRIGLYCERIDES-S.V.R. 06/15/1979
K020488 CARESIDE, INC. CARESIDE TRGLYCERIDE 04/15/2002
K971324 CAROLINA LIQUID CHEMISTRIES CORP. TRIGLYCERIDES, TG, OR TRIG 06/20/1997
K860690 CATACHEM, INC. TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS 03/17/1986
K861635 CATACHEM, INC. TRIGLYCERIDES GPO-TRINDER 06/27/1986
K874584 CIBA CORNING DIAGNOSTICS CORP. TRIGLYERIDES TEST KIT 01/21/1988
K854182 CLINICAL DATA, INC. IN-VITRO TEST DETERMINATION OF TRIALYCERIDE 11/25/1985
K034000 CLINICAL DATA, INC. VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR 03/10/2004
K802256 COLEMAN LABORATORIES CORP. TRIGLYCERIDES DETERMINATION 10/23/1980
K791640 COULTER ELECTRONICS, INC. COULTER ACCU-ZYME II ENZYMATIC REAGENT 09/24/1979
K897159 COULTER ELECTRONICS, INC. COULTER TRIGLYCERIDES GPO REAGENT 03/09/1990
K760195 COULTER ELECTRONICS, INC. REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 08/03/1976
K043546 DADE BEHRING, INC. DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE 01/18/2005
K010871 DADE BEHRING, INC. TGL FLEX REAGENT CARTRIDGE 07/09/2001
K964346 DADE INTL., INC. PARAMAX TRIGLYCERID REAGENT 03/28/1997
K810965 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME TRIGLYCERIDE 04/17/1981
K780379 DATA MEDICAL ASSOCIATES, INC. DATA-ZYME TRIGLYCERIDE PROCEDURE 05/12/1978
K971113 DATA MEDICAL ASSOCIATES, INC. DMA TRIGLYCERIDES PROCEDURES 05/29/1997
K863254 DATA MEDICAL ASSOCIATES, INC. TRIGLYCERIDE (TRINDER) PROCEDURE 09/26/1986
K861670 DATA MEDICAL ASSOCIATES, INC. TRIGLYCERIDE (TRINDER) PROCEDURE 07/01/1986
K851538 DATA MEDICAL ASSOCIATES, INC. TRIGLYCERIDE(TRINDER) PROCEDURE 05/20/1985
K961281 DIAGNOSTIC CHEMICALS LTD. TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 08/16/1996
K960088 DIAGNOSTIC CHEMICALS LTD. TRUE TRIGLYCERIDE 04/01/1996
K843536 DIAGNOSTIC CHEMICALS, LTD. (USA) TRIGLYCERIDE ASSAY KIT GPO-CP 10/11/1984
K812029 EASTMAN KODAK COMPANY KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) 08/03/1981
K863874 ELECTRO-NUCLEONICS LABORATORIES, INC. LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES 11/13/1986
K895952 ELITE TECHNOLOGY, INC. TRIGLYCERIDES TEST KIT 01/11/1990
K915732 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART TIGLYCERIDES REAGENT 01/15/1992
K914018 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 11/22/1991
K870408 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 03/04/1987
K893917 EM DIAGNOSTIC SYSTEMS, INC. EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 08/28/1989
K862706 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95 08/19/1986
K885266 EM DIAGNOSTIC SYSTEMS, INC. OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 02/07/1989
K924573 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST 11/06/1992
K843106 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE TRIGLYCERIDE 67219 08/27/1984
K910638 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 03/11/1991
K924710 EM DIAGNOSTIC SYSTEMS, INC. TRIGLYCERIDES 01/26/1993
K931891 EM DIAGNOSTIC SYSTEMS, INC. TRIGLYCERIDES 08/25/1993
K842211 EM DIAGNOSTIC SYSTEMS, INC. ULTRA CHEM ENZYMATIC TRIGLYCERIDE 07/06/1984
K841471 EM DIAGNOSTIC SYSTEMS, INC. ULTRA CHEM ENZYMATIC TRIGLYCERIDE 05/16/1984
K843832 FERMCO BIOCHEMICS, INC. TRIGLYCERIDES REAGENT SYSTEM 11/27/1984
K781466 FISHER SCIENTIFIC CO., LLC. AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT 10/03/1978
K792480 GENERAL DIAGNOSTICS CHEM-STRATE TRIGLYCERIDE 12/27/1979
K823709 GILFORD DIAGNOSTICS TRIGLYCERIDE REAGENT (UV) 01/07/1983
K760029 HARLECO ENZYMATIC TRIGLYCERIDE 09/15/1976
K780172 HARLECO TRIGLYCERIDE INSTRUMENT APPLICATION 03/09/1978
K812589 HARLECO ULTRA CHEM E-TRIG #65024 09/24/1981
K821875 HARLECO DIAGNOSTICS ULTRACHEM TRI-ES 07/13/1982
K883405 HICHEM DIAGNOSTICS TRIGLYCERIDES REAGENT (PRODUCT #88218) 09/13/1988
K933722 HORIZON DIAGNOSTICS, INC. HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT 06/13/1996
K771472 INSTRUMENTATION LABORATORY CO. MULTISTAT III TRIGLYCERIDE TEST 09/02/1977
K870827 INTERSECT SYSTEMS, INC. INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT 03/13/1987
K863075 J. D. ASSOC. TRIGLYCERIDES-E 09/26/1986
K781240 J.T. BAKER CHEMICAL CO. ENZYMATIC TRIGLYCERIDES REAGENT KIT 08/17/1978
K922964 KING DIAGNOSTICS, INC. KING DIAGNOSTIC TRIGLYCERIDES REAGENT 08/18/1992
K113830 LIPOSCIENCE VANTERA CLINICAL ANALYZER 08/30/2012
K770993 MACOMB CHEMICAL CO. TRIGLYCERIDE REAGENT SET 09/02/1977
K781477 MALLINCKRODT CRITICAL CARE TRIGLYCERIDES TEST KIT 10/03/1978
K834518 MEDICAL ANALYSIS SYSTEMS, INC. LIQUID STABLE TRIGLYCERIDES REAGENT SET 03/02/1984
K952741 MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM 08/17/1995
K841062 MEDICAL SPECIALTIES, INC. TRIGLYCERIDE REAGENT SET 05/01/1984
K771004 MILES LABORATORIES, INC. AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI 09/12/1977
K832684 MILES LABORATORIES, INC. SERALYZER TRIGLYCERIDES REAGENT STRIPS 10/04/1983
K963424 OLYMPUS AMERICA, INC. OLYMPUS LIPASE REAGENT 01/14/1997
K063804 OLYMPUS AMERICA, INC. OLYMPUS TRIGLYCERIDE TEST SYSTEM 03/23/2007
K924694 OLYMPUS CORP. LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC 10/28/1992
K922229 OLYMPUS CORP. OLYMPUS TRIGLYCERIDE REAGENT 07/02/1992
K821205 OMEGA MEDICAL ELECTRONICS TRIGLYCERIDE REAGENT SET 07/20/1982
K130332 ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS TRIG SLIDES 05/31/2013
K897169 PHOTEC DIAGNOSTICS, INC. QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT 02/23/1990
K810680 POINTE SCIENTIFIC, INC. ENZYMATIC TRIGLYCERIDE 03/31/1981
K832871 POINTE SCIENTIFIC, INC. LIPASE HYDROLYSIS/GLYCEROL KINASE 10/14/1983
K862033 POINTE SCIENTIFIC, INC. TRIGLYCERIDES 07/22/1986
K942998 PRISMA SYSTEMS TRIGLYCERODES QVET 11/22/1994
K150819 Randox Laboratories Limited Triglycerides 8/6/2015
K923508 RANDOX LABORATORIES, LTD. TRIGLYCERIDES GPO-PAP 07/28/1993
K800649 REAGENTS APPLICATIONS, INC. ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC 05/08/1980
K803091 REAGENTS APPLICATIONS, INC. TRIGLYCERIDES (UV)-2 REAGENTS 01/09/1981
K801226 REAGENTS APPLICATIONS, INC. TRIGLYCERIDES FOR SMA AND AAII 06/20/1980
K842029 REAGENTS APPLICATIONS, INC. TRIGLYCERIDES-GPO REAGENT 07/09/1984
K801298 ROCHE ANALYTICAL INSTRUMENTS, INC. COBAS REAGENT FOR TRIGLYCERIDES & COBAS 07/08/1980
K896231 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY TRIGLYCERIDE REAGENT 02/16/1990
K893973 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR TRIGLYCERIDES 08/11/1989
K830288 SCLAVO, INC. TRIGLYCERIDE DIAGNOSTIC KIT 02/25/1983
K854783 SCLAVO, INC. TRIGLYCERIDE'S TEST (TRIGLI-CINET) 01/22/1986
K102993 SEPPIM S.A.S. ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL 05/19/2011
K133067 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT 11/22/2013
K800301 SIGMA CHEMICAL CO. SIGMA PROCEDURE & REAGENT SYSTEM #335-UV 03/05/1980
K870012 SIGMA DIAGNOSTICS, INC. TRIGLYCERIDE (GPO-TRINDER) REAGENT 02/20/1987
K844032 SIGMA DIAGNOSTICS, INC. TRIGLYCERIDE REAGENT 11/09/1984
K771904 SIMMLER & SON, INC. GLYCEROL KINASE 12/06/1977
K771905 SIMMLER & SON, INC. GLYCEROL SUBSTRATE 12/06/1977
K771903 SIMMLER & SON, INC. LIPASE 12/06/1977
K771906 SIMMLER & SON, INC. PHOSPHATE 12/06/1977
K811850 SMITH KLINE DIAGNOSTICS, INC. ESKAFLOW TEST FOR TRIGLYCERIDES 07/23/1981
K812471 SMITH KLINE DIAGNOSTICS, INC. SPIN-CHEM TRIGLYCERIDES REAGENT 09/14/1981
K832444 STANBIO LABORATORY ENZYMATIC TRIGLYCERIDES #2000 08/31/1983
K831858 STANBIO LABORATORY TRIGLYCERIDES REAGENT SET 07/22/1983
K823341 STERLING BIOCHEMICAL, INC. TRIGLYCERIDES REAGENT SET TAG-GK 12/22/1982
K855164 STERLING DIAGNOSTICS, INC. ENZYNATIC TRIGLYCERIDES REAGENT SET 02/19/1986
K914609 STERLING DIAGNOSTICS, INC. TRIGLYCERIDES REAGENT SET 11/07/1991
K903016 SYNERMED, INC. SYNERMED TRIGLYCERIDES REAGENT KIT 07/27/1990
K863923 TECH-CO, INC. TRIGLYCERIDES 11/24/1986
K880628 TECH-CO, INC. TRIGLYCERIDES (GPO-TRINDER) 03/15/1988
K880238 TECH-NEAL SCIENTIFIC, INC. TRIGLYCERIDE 03/15/1988
K854152 TECHNICON INSTRUMENTS CORP. TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN 11/05/1985
K821315 THE DOW CHEMICAL CO. DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM 05/24/1982
K760011 THE DOW CHEMICAL CO. REAGENT, TRIGLYCERIDES 07/26/1976
K961477 TRACE AMERICA, INC. TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY 08/05/1996
K953971 TRACE AMERICA, INC. TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY 04/05/1996
K860730 TRACE SCIENTIFIC LTD. ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) 04/07/1986
K871508 TRACE SCIENTIFIC LTD. RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL 05/08/1987
K871509 TRACE SCIENTIFIC LTD. RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) 05/08/1987
K903897 TRACE SCIENTIFIC LTD. TRIGLYCERIDES REAGENT GPO 5 X CONC. 10/01/1990
K864231 U. S. DIAGNOSTICS, INC. U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST 12/04/1986
K770841 UNION CARBIDE CORP. TRIGLYCERIDE ENZYMATIC METHOD 07/14/1977
K993466 WAKO CHEMICALS, USA, INC. WAKO L-TYPE TRIGLYCERIDE TEST 11/09/1999
K791597 WAKO PURE CHEMICAL INDUSTRIES, LTD. WAKO TRIGLYCERIDE 09/17/1979
K801891 WAKO PURE CHEMICAL INDUSTRIES, LTD. WAKO TRIGLYCERIDE-G TEST 09/16/1980
K761262 WORTHINGTON BIOCHEMICAL CORP. TRIGLYCERIDES (LIPASE) REAGENT SET 12/29/1976
K832426 WORTHINGTON DIAGNOSTIC SYSTEMS EASYTOUCH TRIGLYCERIDES REAGENT SET 09/12/1983


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