Atlas FDA

CDT

151 FDA 510(k) clearances · Product code

45 daysmedian time to decision
108 days90th percentile
151clearances measured

FDA profile

Official device name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device class
Class I (low risk)
Regulation
21 CFR 862.1705
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2010: 3 · 2011: 11 · 2012: 4 · 2016: 12 · 2026: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Triglycerides (K150819)Randox Laboratories Limited2015-08-06
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (K133067)Siemens Healthcare Diagnostics, Inc.2013-11-22
VITROS CHEMISTRY PRODUCTS TRIG SLIDES (K130332)Ortho-Clinical Diagnostics, Inc.2013-05-31
VANTERA CLINICAL ANALYZER (K113830)Liposcience2012-08-30
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL (K102993)Seppim S.A.S.2011-05-19
OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804)Olympus America, Inc.2007-03-23
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (K043546)Dade Behring, Inc.2005-01-18
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (K034000)Clinical Data, Inc.2004-03-10
CARESIDE TRGLYCERIDE (K020488)Careside, Inc.2002-04-15
TGL FLEX REAGENT CARTRIDGE (K010871)Dade Behring, Inc.2001-07-09
WAKO L-TYPE TRIGLYCERIDE TEST (K993466)Wako Chemicals USA, Inc.1999-11-09
TRIGLYCERIDES, TG, OR TRIG (K971324)Carolina Liquid Chemistries Corp.1997-06-20
DMA TRIGLYCERIDES PROCEDURES (K971113)Data Medical Associates, Inc.1997-05-29
PARAMAX TRIGLYCERID REAGENT (K964346)Dade Intl., Inc.1997-03-28
OLYMPUS LIPASE REAGENT (K963424)Olympus America, Inc.1997-01-14
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 (K961281)Diagnostic Chemicals , Ltd.1996-08-16
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (K961477)Trace America, Inc.1996-08-05
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (K933722)Horizon Diagnostics, Inc.1996-06-13
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY (K953971)Trace America, Inc.1996-04-05
TRUE TRIGLYCERIDE (K960088)Diagnostic Chemicals , Ltd.1996-04-01
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM (K952741)Medical Diagnostic Technologies, Inc.1995-08-17
TRIGLYCERODES QVET (K942998)Prisma Systems1994-11-22
TRIGLYCERIDES (K931891)Em Diagnostic Systems, Inc.1993-08-25
TRIGLYCERIDES GPO-PAP (K923508)Randox Laboratories, Ltd.1993-07-28
TRIGLYCERIDES (K924710)Em Diagnostic Systems, Inc.1993-01-26
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST (K924573)Em Diagnostic Systems, Inc.1992-11-06
LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC (K924694)Olympus Corp.1992-10-28
KING DIAGNOSTIC TRIGLYCERIDES REAGENT (K922964)King Diagnostics, Inc.1992-08-18
OLYMPUS TRIGLYCERIDE REAGENT (K922229)Olympus Corp.1992-07-02
BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT (K915084)Beckman Instruments, Inc.1992-01-28
ABBOTT QUICKSTART TIGLYCERIDES REAGENT (K915732)Em Diagnostic Systems, Inc.1992-01-15
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 (K914018)Em Diagnostic Systems, Inc.1991-11-22
TRIGLYCERIDES REAGENT SET (K914609)Sterling Diagnostics, Inc.1991-11-07
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 (K910638)Em Diagnostic Systems, Inc.1991-03-11
ECLIPSE ICA TRIGLYCERIDES (K905601)Biotope, Inc.1991-01-17
TRIGLYCERIDES REAGENT GPO 5 X CONC. (K903897)Trace Scientific , Ltd.1990-10-01
SYNERMED TRIGLYCERIDES REAGENT KIT (K903016)Synermed, Inc.1990-07-27
COULTER TRIGLYCERIDES GPO REAGENT (K897159)Coulter Electronics, Inc.1990-03-09
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT (K897169)Photec Diagnostics, Inc.1990-02-23
COBAS READY TRIGLYCERIDE REAGENT (K896231)Roche Diagnostic Systems, Inc.1990-02-16
TRIGLYCERIDES TEST KIT (K895952)Elite Technology, Inc.1990-01-11
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730) (K894310)American Research Products Co.1989-09-28
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 (K893917)Em Diagnostic Systems, Inc.1989-08-28
ROCHE REAGENT FOR TRIGLYCERIDES (K893973)Roche Diagnostic Systems, Inc.1989-08-11
TRIGLYCERIDES - GPO REAGENT (K890337)Alpkem Corp.1989-03-09
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 (K885266)Em Diagnostic Systems, Inc.1989-02-07
TRIGLYCERIDES REAGENT (PRODUCT #88218) (K883405)Hichem Diagnostics1988-09-13
BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. (K881702)Biotrol, USA, Inc.1988-05-27
TRIGLYCERIDE (K880238)Tech-Neal Scientific, Inc.1988-03-15
TRIGLYCERIDES (GPO-TRINDER) (K880628)Tech-Co, Inc.1988-03-15
A-GENT TRIGLLYCERIDES GPO (K874187)Abbott Laboratories1988-01-21
TRIGLYERIDES TEST KIT (K874584)Ciba Corning Diagnostics Corp.1988-01-21
BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR (K873160)Biotrol, USA, Inc.1987-09-08
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL (K873049)Boehringer Mannheim Corp.1987-08-28
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL (K871508)Trace Scientific , Ltd.1987-05-08
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) (K871509)Trace Scientific , Ltd.1987-05-08
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD (K871301)American Monitor Corp.1987-04-22
TRIGLYCERIDES DETERMINATION (K871122)Biochemical Trade, Inc.1987-04-07
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT (K870827)Intersect Systems, Inc.1987-03-13
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 (K870408)Em Diagnostic Systems, Inc.1987-03-04
TRIGLYCERIDE (GPO-TRINDER) REAGENT (K870012)Sigma Diagnostics, Inc.1987-02-20
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT (K864939)Beckman Instruments, Inc.1986-12-31
IQ TRIGLYCERIDES (K864268)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST (K864231)U. S. Diagnostics, Inc.1986-12-04
TRIGLYCERIDES (K863923)Tech-Co, Inc.1986-11-24
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (K863874)Electro-Nucleonics Laboratories, Inc.1986-11-13
TRIGLYCERIDE (TRINDER) PROCEDURE (K863254)Data Medical Associates, Inc.1986-09-26
TRIGLYCERIDES-E (K863075)J. D. Assoc.1986-09-26
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95 (K862706)Em Diagnostic Systems, Inc.1986-08-19
TRIGLYCERIDES (K862033)Pointe Scientific, Inc.,1986-07-22
TRIGLYCERIDE (TRINDER) PROCEDURE (K861670)Data Medical Associates, Inc.1986-07-01
TWIN TRIGLYCERIDES GPO/CHOLESTEROL (K861793)Boehringer Mannheim Corp.1986-06-27
TRIGLYCERIDES GPO-TRINDER (K861635)Catachem, Inc.1986-06-27
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) (K860730)Trace Scientific , Ltd.1986-04-07
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS (K860690)Catachem, Inc.1986-03-17
ENZYNATIC TRIGLYCERIDES REAGENT SET (K855164)Sterling Diagnostics, Inc.1986-02-19
TRIGLYCERIDE'S TEST (TRIGLI-CINET) (K854783)Sclavo, Inc.1986-01-22
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE (K854182)Clinical Data, Inc.1985-11-25
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD (K854366)American Monitor Corp.1985-11-25
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN (K854152)Technicon Instruments Corp.1985-11-05
TGL REAGENT (K852010)Alpkem Corp.1985-05-30
TRIGLYCERIDE(TRINDER) PROCEDURE (K851538)Data Medical Associates, Inc.1985-05-20
PERIDOCHROM TRIGLYCERIDES GPO (K850667)Boehringer Mannheim Corp.1985-03-11
VISION TRIGLYCERIDES (K850031)Abbott Laboratories1985-02-04
TRIGLYCERIDES REAGENT SYSTEM (K843832)Fermco Biochemics, Inc.1984-11-27
TRIGLYCERIDE REAGENT (K844032)Sigma Diagnostics, Inc.1984-11-09
TRIGLYCERIDE ASSAY KIT GPO-CP (K843536)Diagnostic Chemicals, Ltd. (Usa)1984-10-11
TRIGLYCERIDES GPO REAGENT (K843552)Bio-Rad1984-09-26
AXIOM STABLE II TRIGLYCERIDES TEST (K842443)Axiom, Inc.1984-09-13
SYSTEMATE TRIGLYCERIDE 67219 (K843106)Em Diagnostic Systems, Inc.1984-08-27
QCA TRIGLYCERIDES (K842891)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-22
TRIGLYCERIDES-GPO REAGENT (K842029)Reagents Applications, Inc.1984-07-09
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K842211)Em Diagnostic Systems, Inc.1984-07-06
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K841471)Em Diagnostic Systems, Inc.1984-05-16
TRIGLYCERIDE REAGENT SET (K841062)Medical Specialties, Inc.1984-05-01
TRIGLYCERIDES REAGENT (K840780)American Dade1984-04-05
LIQUID STABLE TRIGLYCERIDES REAGENT SET (K834518)Medical Analysis Systems, Inc.1984-03-02
REAGENT SET TRIGLYCERIDES GPO (K833082)Boehringer Mannheim Corp.1983-11-25
LIPASE HYDROLYSIS/GLYCEROL KINASE (K832871)Pointe Scientific, Inc.,1983-10-14
SERALYZER TRIGLYCERIDES REAGENT STRIPS (K832684)Miles Laboratories, Inc.1983-10-04
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