Product Code: JGY FDA class 1 21 CFR 862.1705

Colorimetric Method, Triglycerides

Clinical Chemistry

Colorimetric Method for Triglycerides is a clinical chemistry test system that quantifies serum triglycerides through colorimetric enzymatic reactions, widely used in lipid panels to assess cardiovascular risk, hyperlipidemia, and metabolic syndrome. It is classified as FDA Class 1 (lowest risk), subject only to general controls including proper labeling and manufacturing standards. The product code is JGY, regulated under 21 CFR 862.1705, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: JGY
Device Class: FDA class 1
Regulation Number: 862.1705
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

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