FDA Product Code
FDA Product Code CDT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1705
510(k) Clearances — 151 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150819 | Triglycerides | Randox Laboratories Limited | 2015-08-06 | Traditional | PDF ↗ |
| K133067 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT | Siemens Healthcare Diagnostics, Inc. | 2013-11-22 | Traditional | PDF ↗ |
| K130332 | VITROS CHEMISTRY PRODUCTS TRIG SLIDES | Ortho-Clinical Diagnostics, Inc. | 2013-05-31 | Special | PDF ↗ |
| K113830 | VANTERA CLINICAL ANALYZER | Liposcience | 2012-08-30 | Traditional | PDF ↗ |
| K102993 | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | Seppim S.A.S. | 2011-05-19 | Traditional | PDF ↗ |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Olympus America, Inc. | 2007-03-23 | Traditional | PDF ↗ |
| K043546 | DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE | Dade Behring, Inc. | 2005-01-18 | Special | PDF ↗ |
| K034000 | VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR | Clinical Data, Inc. | 2004-03-10 | Traditional | PDF ↗ |
| K020488 | CARESIDE TRGLYCERIDE | Careside, Inc. | 2002-04-15 | Traditional | PDF ↗ |
| K010871 | TGL FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2001-07-09 | Traditional | PDF ↗ |
| K993466 | WAKO L-TYPE TRIGLYCERIDE TEST | Wako Chemicals USA, Inc. | 1999-11-09 | Traditional | PDF ↗ |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | Carolina Liquid Chemistries Corp. | 1997-06-20 | Traditional | PDF ↗ |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | Data Medical Associates, Inc. | 1997-05-29 | Traditional | PDF ↗ |
| K964346 | PARAMAX TRIGLYCERID REAGENT | Dade Intl., Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K963424 | OLYMPUS LIPASE REAGENT | Olympus America, Inc. | 1997-01-14 | Traditional | PDF ↗ |
| K961281 | TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 | Diagnostic Chemicals , Ltd. | 1996-08-16 | Traditional | PDF ↗ |
| K961477 | TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY | Trace America, Inc. | 1996-08-05 | Traditional | PDF ↗ |
| K933722 | HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT | Horizon Diagnostics, Inc. | 1996-06-13 | Traditional | PDF ↗ |
| K953971 | TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY | Trace America, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K960088 | TRUE TRIGLYCERIDE | Diagnostic Chemicals , Ltd. | 1996-04-01 | Traditional | PDF ↗ |
| K952741 | TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-17 | Traditional | PDF ↗ |
| K942998 | TRIGLYCERODES QVET | Prisma Systems | 1994-11-22 | Traditional | PDF ↗ |
| K931891 | TRIGLYCERIDES | Em Diagnostic Systems, Inc. | 1993-08-25 | Traditional | PDF ↗ |
| K923508 | TRIGLYCERIDES GPO-PAP | Randox Laboratories, Ltd. | 1993-07-28 | Traditional | PDF ↗ |
| K924710 | TRIGLYCERIDES | Em Diagnostic Systems, Inc. | 1993-01-26 | Traditional | PDF ↗ |
| K924573 | SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST | Em Diagnostic Systems, Inc. | 1992-11-06 | Traditional | PDF ↗ |
| K924694 | LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC | Olympus Corp. | 1992-10-28 | Traditional | PDF ↗ |
| K922964 | KING DIAGNOSTIC TRIGLYCERIDES REAGENT | King Diagnostics, Inc. | 1992-08-18 | Traditional | PDF ↗ |
| K922229 | OLYMPUS TRIGLYCERIDE REAGENT | Olympus Corp. | 1992-07-02 | Traditional | PDF ↗ |
| K915084 | BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT | Beckman Instruments, Inc. | 1992-01-28 | Traditional | PDF ↗ |
| K915732 | ABBOTT QUICKSTART TIGLYCERIDES REAGENT | Em Diagnostic Systems, Inc. | 1992-01-15 | Traditional | PDF ↗ |
| K914018 | ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 | Em Diagnostic Systems, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K914609 | TRIGLYCERIDES REAGENT SET | Sterling Diagnostics, Inc. | 1991-11-07 | Traditional | PDF ↗ |
| K910638 | SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 | Em Diagnostic Systems, Inc. | 1991-03-11 | Traditional | PDF ↗ |
| K905601 | ECLIPSE ICA TRIGLYCERIDES | Biotope, Inc. | 1991-01-17 | Traditional | PDF ↗ |
| K903897 | TRIGLYCERIDES REAGENT GPO 5 X CONC. | Trace Scientific , Ltd. | 1990-10-01 | Traditional | PDF ↗ |
| K903016 | SYNERMED TRIGLYCERIDES REAGENT KIT | Synermed, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K897159 | COULTER TRIGLYCERIDES GPO REAGENT | Coulter Electronics, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K897169 | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT | Photec Diagnostics, Inc. | 1990-02-23 | Traditional | PDF ↗ |
| K896231 | COBAS READY TRIGLYCERIDE REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K895952 | TRIGLYCERIDES TEST KIT | Elite Technology, Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K894310 | AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730) | American Research Products Co. | 1989-09-28 | Traditional | PDF ↗ |
| K893917 | EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 | Em Diagnostic Systems, Inc. | 1989-08-28 | Traditional | PDF ↗ |
| K893973 | ROCHE REAGENT FOR TRIGLYCERIDES | Roche Diagnostic Systems, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K890337 | TRIGLYCERIDES - GPO REAGENT | Alpkem Corp. | 1989-03-09 | Traditional | PDF ↗ |
| K885266 | OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 | Em Diagnostic Systems, Inc. | 1989-02-07 | Traditional | PDF ↗ |
| K883405 | TRIGLYCERIDES REAGENT (PRODUCT #88218) | Hichem Diagnostics | 1988-09-13 | Traditional | PDF ↗ |
| K881702 | BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. | Biotrol, USA, Inc. | 1988-05-27 | Traditional | PDF ↗ |
| K880238 | TRIGLYCERIDE | Tech-Neal Scientific, Inc. | 1988-03-15 | Traditional | PDF ↗ |
| K880628 | TRIGLYCERIDES (GPO-TRINDER) | Tech-Co, Inc. | 1988-03-15 | Traditional | PDF ↗ |
| K874187 | A-GENT TRIGLLYCERIDES GPO | Abbott Laboratories | 1988-01-21 | Traditional | PDF ↗ |
| K874584 | TRIGLYERIDES TEST KIT | Ciba Corning Diagnostics Corp. | 1988-01-21 | Traditional | PDF ↗ |
| K873160 | BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR | Biotrol, USA, Inc. | 1987-09-08 | Traditional | PDF ↗ |
| K873049 | TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL | Boehringer Mannheim Corp. | 1987-08-28 | Traditional | PDF ↗ |
| K871508 | RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL | Trace Scientific , Ltd. | 1987-05-08 | Traditional | PDF ↗ |
| K871509 | RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) | Trace Scientific , Ltd. | 1987-05-08 | Traditional | PDF ↗ |
| K871301 | ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD | American Monitor Corp. | 1987-04-22 | Traditional | PDF ↗ |
| K871122 | TRIGLYCERIDES DETERMINATION | Biochemical Trade, Inc. | 1987-04-07 | Traditional | PDF ↗ |
| K870827 | INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT | Intersect Systems, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K870408 | EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 | Em Diagnostic Systems, Inc. | 1987-03-04 | Traditional | PDF ↗ |
| K870012 | TRIGLYCERIDE (GPO-TRINDER) REAGENT | Sigma Diagnostics, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K864939 | BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT | Beckman Instruments, Inc. | 1986-12-31 | Traditional | PDF ↗ |
| K864268 | IQ TRIGLYCERIDES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-12-16 | Traditional | PDF ↗ |
| K864231 | U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST | U. S. Diagnostics, Inc. | 1986-12-04 | Traditional | PDF ↗ |
| K863923 | TRIGLYCERIDES | Tech-Co, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K863874 | LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES | Electro-Nucleonics Laboratories, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K863254 | TRIGLYCERIDE (TRINDER) PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863075 | TRIGLYCERIDES-E | J. D. Assoc. | 1986-09-26 | Traditional | PDF ↗ |
| K862706 | EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95 | Em Diagnostic Systems, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862033 | TRIGLYCERIDES | Pointe Scientific, Inc., | 1986-07-22 | Traditional | PDF ↗ |
| K861670 | TRIGLYCERIDE (TRINDER) PROCEDURE | Data Medical Associates, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K861793 | TWIN TRIGLYCERIDES GPO/CHOLESTEROL | Boehringer Mannheim Corp. | 1986-06-27 | Traditional | PDF ↗ |
| K861635 | TRIGLYCERIDES GPO-TRINDER | Catachem, Inc. | 1986-06-27 | Traditional | PDF ↗ |
| K860730 | ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) | Trace Scientific , Ltd. | 1986-04-07 | Traditional | PDF ↗ |
| K860690 | TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS | Catachem, Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K855164 | ENZYNATIC TRIGLYCERIDES REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K854783 | TRIGLYCERIDE'S TEST (TRIGLI-CINET) | Sclavo, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K854366 | ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD | American Monitor Corp. | 1985-11-25 | Traditional | PDF ↗ |
| K854182 | IN-VITRO TEST DETERMINATION OF TRIALYCERIDE | Clinical Data, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K854152 | TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN | Technicon Instruments Corp. | 1985-11-05 | Traditional | PDF ↗ |
| K852010 | TGL REAGENT | Alpkem Corp. | 1985-05-30 | Traditional | PDF ↗ |
| K851538 | TRIGLYCERIDE(TRINDER) PROCEDURE | Data Medical Associates, Inc. | 1985-05-20 | Traditional | PDF ↗ |
| K850667 | PERIDOCHROM TRIGLYCERIDES GPO | Boehringer Mannheim Corp. | 1985-03-11 | Traditional | PDF ↗ |
| K850031 | VISION TRIGLYCERIDES | Abbott Laboratories | 1985-02-04 | Traditional | PDF ↗ |
| K843832 | TRIGLYCERIDES REAGENT SYSTEM | Fermco Biochemics, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K844032 | TRIGLYCERIDE REAGENT | Sigma Diagnostics, Inc. | 1984-11-09 | Traditional | PDF ↗ |
| K843536 | TRIGLYCERIDE ASSAY KIT GPO-CP | Diagnostic Chemicals, Ltd. (Usa) | 1984-10-11 | Traditional | PDF ↗ |
| K843552 | TRIGLYCERIDES GPO REAGENT | Bio-Rad | 1984-09-26 | Traditional | PDF ↗ |
| K842443 | AXIOM STABLE II TRIGLYCERIDES TEST | Axiom, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K843106 | SYSTEMATE TRIGLYCERIDE 67219 | Em Diagnostic Systems, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K842891 | QCA TRIGLYCERIDES | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-08-22 | Traditional | PDF ↗ |
| K842029 | TRIGLYCERIDES-GPO REAGENT | Reagents Applications, Inc. | 1984-07-09 | Traditional | PDF ↗ |
| K842211 | ULTRA CHEM ENZYMATIC TRIGLYCERIDE | Em Diagnostic Systems, Inc. | 1984-07-06 | Traditional | PDF ↗ |
| K841471 | ULTRA CHEM ENZYMATIC TRIGLYCERIDE | Em Diagnostic Systems, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K841062 | TRIGLYCERIDE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840780 | TRIGLYCERIDES REAGENT | American Dade | 1984-04-05 | Traditional | PDF ↗ |
| K834518 | LIQUID STABLE TRIGLYCERIDES REAGENT SET | Medical Analysis Systems, Inc. | 1984-03-02 | Traditional | PDF ↗ |
| K833082 | REAGENT SET TRIGLYCERIDES GPO | Boehringer Mannheim Corp. | 1983-11-25 | Traditional | PDF ↗ |
| K832871 | LIPASE HYDROLYSIS/GLYCEROL KINASE | Pointe Scientific, Inc., | 1983-10-14 | Traditional | PDF ↗ |
| K832684 | SERALYZER TRIGLYCERIDES REAGENT STRIPS | Miles Laboratories, Inc. | 1983-10-04 | Traditional | PDF ↗ |
Product code CDT · Class I · Clinical Chemistry. Data: openFDA.