JME · Radioimmunoassay, Glucagon
Clinical Chemistry · 21 CFR 862.1335 · Class 1
Overview
| Product Code | JME |
|---|---|
| Device Name | Radioimmunoassay, Glucagon |
| Regulation | 21 CFR 862.1335 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A glucagon test system is a device intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia.
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 (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893975 | DOUBLE ANTIBODY GLUCAGON | Diagnostic Products Corp. | Oct 31, 1989 | SESE |
| K782143 | RIA KIT, GLUCOSE | Serono Laboratories, Inc. | Feb 22, 1979 | SESE |
| K771948 | GLUCAGON RIA MODULE | Inter Science Institute | Jan 20, 1978 | SESE |
Top Applicants
- Serono Laboratories, Inc. — 1 clearance
- Inter Science Institute — 1 clearance
- Diagnostic Products Corp. — 1 clearance
