RIA KIT, GLUCOSE
Device Facts
| Record ID | K782143 |
|---|---|
| Device Name | RIA KIT, GLUCOSE |
| Applicant | Serono Laboratories, Inc. |
| Product Code | JME · Clinical Chemistry |
| Decision Date | Feb 22, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1335 |
| Device Class | Class 1 |
Regulatory Classification
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.
