JGY · Colorimetric Method, Triglycerides
Clinical Chemistry · 21 CFR 862.1705 · Class 1
Overview
| Product Code | JGY |
|---|---|
| Device Name | Colorimetric Method, Triglycerides |
| Regulation | 21 CFR 862.1705 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (22)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120664 | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM | Abaxis, Inc. | Apr 24, 2012 | SESE |
| K023639 | PICCOLO TRIGLYCERIDES TEST SYSTEM | Abaxis, Inc. | Jan 24, 2003 | SESE |
| K000586 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | Polymer Technology Systems, Inc. | Jul 3, 2000 | SESE |
| K991894 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | Polymer Technology Systems, Inc. | May 24, 2000 | SESE |
| K971005 | TRIGLYCERIDES | Derma Media Lab., Inc. | Apr 21, 1997 | SESE |
| K954187 | TRIGLYCERIDES REAGENT | Schiapparelli Biosystems, Inc. | Oct 23, 1995 | SESE |
| K941063 | DNA TRIGLYCERIDE PROCEDURE | Data Medical Associates, Inc. | Jul 20, 1994 | SESE |
| K931116 | IL TEST(TM) TRIGLYCERIDE | Instrumentation Laboratory CO | Mar 28, 1994 | SESE |
| K914033 | CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST | Cholestech Corp. | Sep 27, 1991 | SESE |
| K905226 | TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | Dec 11, 1990 | SESE |
| K902202 | DMA TRIGLYCERIDE (GPO) PROCEDURE | Data Medical Associates, Inc. | Jul 31, 1990 | SESE |
| K894063 | TRIGLYCERIDE (GPO) TRINDER REAGENT | Sigma Diagnostics, Inc. | Sep 7, 1989 | SESE |
| K885134 | CLINISTAT TRIGLYCERIDES REAGENT TEST | Heraeus Kulzer, Inc. | Feb 10, 1989 | SESE |
| K860731 | TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) | Trace Scientific , Ltd. | Apr 7, 1986 | SESE |
| K832460 | TRIGLYCERIDE REAGENT-TRINDER-GPO | Seppim, Inc. | Sep 12, 1983 | SESE |
| K821106 | TRIGLYZYME V EIKEN | Syn-Kit, Inc. | May 5, 1982 | SESE |
| K801012 | TRIGLYCERIDE REAGENT (COLOR) | Gilford Diagnostics | May 14, 1980 | SESE |
| K800551 | TRIGLYCERIDES TEST (500NM) | Reagents Applications, Inc. | Mar 25, 1980 | SESE |
| K792414 | ELVI TRIGLYCERIDE | Volu Sol Medical Industries | Dec 7, 1979 | SESE |
| K791962 | WORTHINGTON TRIGLYCERIDES REAGENT SET | Worthington Diagnostic Systems | Nov 5, 1979 | SESE |
| K780825 | TRIGLYCERIDE C-37 RAPID STAT KIT | Pierce Chemical Co. | May 26, 1978 | SESE |
| K761283 | TRI-CON TRIGLYCERIDGE REAGENTS | Dade, Baxter Travenol Diagnostics, Inc. | Feb 24, 1977 | SESE |
Top Applicants
- Polymer Technology Systems, Inc. — 2 clearances
- Data Medical Associates, Inc. — 2 clearances
- Abaxis, Inc. — 2 clearances
- Worthington Diagnostic Systems — 1 clearance
- Volu Sol Medical Industries — 1 clearance
