FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K020488 |
CARESIDE, INC. |
CARESIDE TRGLYCERIDE |
04/15/2002 |
K971324 |
CAROLINA LIQUID CHEMISTRIES CORP. |
TRIGLYCERIDES, TG, OR TRIG |
06/20/1997 |
K034000 |
CLINICAL DATA, INC. |
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR |
03/10/2004 |
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 |
K971113 |
DATA MEDICAL ASSOCIATES, INC. |
DMA TRIGLYCERIDES PROCEDURES |
05/29/1997 |
K961281 |
DIAGNOSTIC CHEMICALS LTD. |
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 |
08/16/1996 |
K960088 |
DIAGNOSTIC CHEMICALS LTD. |
TRUE TRIGLYCERIDE |
04/01/1996 |
K933722 |
HORIZON DIAGNOSTICS, INC. |
HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT |
06/13/1996 |
K113830 |
LIPOSCIENCE |
VANTERA CLINICAL ANALYZER |
08/30/2012 |
K963424 |
OLYMPUS AMERICA, INC. |
OLYMPUS LIPASE REAGENT |
01/14/1997 |
K063804 |
OLYMPUS AMERICA, INC. |
OLYMPUS TRIGLYCERIDE TEST SYSTEM |
03/23/2007 |
K130332 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS TRIG SLIDES |
05/31/2013 |
K150819 |
Randox Laboratories Limited |
Triglycerides |
08/06/2015 |
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 |
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 |
K993466 |
WAKO CHEMICALS, USA, INC. |
WAKO L-TYPE TRIGLYCERIDE TEST |
11/09/1999 |