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 |
K861670 |
DATA MEDICAL ASSOCIATES, INC. |
TRIGLYCERIDE (TRINDER) PROCEDURE |
07/01/1986 |
K863254 |
DATA MEDICAL ASSOCIATES, INC. |
TRIGLYCERIDE (TRINDER) PROCEDURE |
09/26/1986 |
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 |