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 | 08/06/2015 |
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
