JGX · Turbidimetric Method, Triglycerides
Clinical Chemistry · 21 CFR 862.1705 · Class 1
Overview
| Product Code | JGX |
|---|---|
| Device Name | Turbidimetric 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831874 | LIPASE REAGENT SET | Sterling Biochemical, Inc. | Aug 12, 1983 | SESE |
Top Applicants
- Sterling Biochemical, Inc. — 1 clearance
