JGW · Fluorometric Method, Triglycerides
Clinical Chemistry · 21 CFR 862.1705 · Class 1
Overview
| Product Code | JGW |
|---|---|
| Device Name | Fluorometric 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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872912 | TRIGLYCERIDE (UV) REAGENT | Sigma Chemical Co. | Aug 17, 1987 | SESE |
| K852556 | TDX REA TRIGLYCERIDES | Abbott Laboratories | Jul 22, 1985 | SESE |
| K780439 | PRECIMAT GLYCEROL | Boehringer Mannheim Corp. | Apr 18, 1978 | SESE |
Top Applicants
- Sigma Chemical Co. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Abbott Laboratories — 1 clearance
