Product code JGY

Device name: Colorimetric Method, Triglycerides
Medical specialty: Clinical Chemistry
Device class: 1
Regulation number: 862.1705
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K120664	PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM	Abaxis, Inc.	2012-04-24
K023639	PICCOLO TRIGLYCERIDES TEST SYSTEM	Abaxis, Inc.	2003-01-24
K000586	BIOSCANNER TRIGLYCERIDES TEST STRIPS	Polymer Technology Systems, Inc.	2000-07-03
K991894	BIOSCANNER TRIGLYCERIDES TEST STRIPS	Polymer Technology Systems, Inc.	2000-05-24
K971005	TRIGLYCERIDES	Derma Media Lab., Inc.	1997-04-21
K954187	TRIGLYCERIDES REAGENT	Schiapparelli Biosystems, Inc.	1995-10-23
K941063	DNA TRIGLYCERIDE PROCEDURE	Data Medical Associates, Inc.	1994-07-20
K931116	IL TEST(TM) TRIGLYCERIDE	Instrumentation Laboratory CO	1994-03-28
K914033	CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST	Cholestech Corp.	1991-09-27
K905226	TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL	Enzyme Technology, Inc.	1990-12-11
K902202	DMA TRIGLYCERIDE (GPO) PROCEDURE	Data Medical Associates, Inc.	1990-07-31
K894063	TRIGLYCERIDE (GPO) TRINDER REAGENT	Sigma Diagnostics, Inc.	1989-09-07
K885134	CLINISTAT TRIGLYCERIDES REAGENT TEST	Heraeus Kulzer, Inc.	1989-02-10
K860731	TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)	Trace Scientific , Ltd.	1986-04-07
K832460	TRIGLYCERIDE REAGENT-TRINDER-GPO	Seppim, Inc.	1983-09-12
K821106	TRIGLYZYME V EIKEN	Syn-Kit, Inc.	1982-05-05
K801012	TRIGLYCERIDE REAGENT (COLOR)	Gilford Diagnostics	1980-05-14
K800551	TRIGLYCERIDES TEST (500NM)	Reagents Applications, Inc.	1980-03-25
K792414	ELVI TRIGLYCERIDE	Volu Sol Medical Industries	1979-12-07
K791962	WORTHINGTON TRIGLYCERIDES REAGENT SET	Worthington Diagnostic Systems	1979-11-05
K780825	TRIGLYCERIDE C-37 RAPID STAT KIT	Pierce Chemical Co.	1978-05-26
K761283	TRI-CON TRIGLYCERIDGE REAGENTS	Dade, Baxter Travenol Diagnostics, Inc.	1977-02-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00682607690084	Mission Cholesterol Control Solution	Acon Laboratories, Inc.	2026-03-09
00682607690077	Mission Cholesterol Optical Check Device	Acon Laboratories, Inc.	2026-03-09
00682607690053	Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25T	Acon Laboratories, Inc.	2026-03-09
00381934753010	Lipid Panel, 15ct., CCPlus Home	POLYMER TECHNOLOGY SYSTEMS, INC.	2023-06-20
00381934752013	Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)	POLYMER TECHNOLOGY SYSTEMS, INC.	2023-06-01
00381934749013	Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus Home	POLYMER TECHNOLOGY SYSTEMS, INC.	2023-03-25
00381934747019	Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus Home	POLYMER TECHNOLOGY SYSTEMS, INC.	2023-03-25
00381934750019	CardioChek Plus Home Self-Test Analyzer	POLYMER TECHNOLOGY SYSTEMS, INC.	2022-04-11
08809115905406	CURO L5 Meter	OSANG HEALTHCARE Co., Ltd.	2021-07-09
00381934722016	CardioChek Plus Home Lipid Panel Self-Test Strip 2ct	POLYMER TECHNOLOGY SYSTEMS, INC.	2021-02-08
00381934721019	CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct	POLYMER TECHNOLOGY SYSTEMS, INC.	2021-02-08
00381934720012	CardioChek Plus Home Self-Test Analyzer	POLYMER TECHNOLOGY SYSTEMS, INC.	2021-02-08
08809319396161	CURO L7 Analyzer	SD Biosensor, Inc.	2020-04-21
08809319396512	CURO L7 Lipid Test Strip - Lipid Profile	SD Biosensor, Inc.	2020-04-21
00381932478014	CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk)	POLYMER TECHNOLOGY SYSTEMS, INC.	2019-10-15
10763924550507	LipidPlus® Meter	JANT PHARMACAL CORPORATION	2017-02-16
00304040040539	CardioChek	HENRY SCHEIN, INC.	2017-01-16
00304040037713	CardioChek	HENRY SCHEIN, INC.	2017-01-05
10304040037741	CardioChek	HENRY SCHEIN, INC.	2017-01-05
10304040037734	CardioChek	HENRY SCHEIN, INC.	2017-01-05
00381931716018	PTS Panels® Triglycerides Test Strips	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-22
00381932700016	CardioChek® Plus Professional Analyzer	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15
00381932701013	CardioChek® Plus Professional Analyzer	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15
00381932702010	CardioChek® Plus Professional Analyzer, Refurbished	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15
00381932729017	CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk)	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15
00381931782013	CardioChek® Analyzer; Refurbished	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15
00381931709010	CardioChek® Analyzer	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15
00381931708013	CardioChek® PA analyzer	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15
00381930860019	ChekMate™ Strips	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15
00381932400015	PTS Panels Metabolic ChemistryTest Strips (15-ct)	POLYMER TECHNOLOGY SYSTEMS, INC.	2016-07-15

Product code JGY

Related 510(k) Records#

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