DOUBLE ANTIBODY GLUCAGON
Device Facts
| Record ID | K893975 |
|---|---|
| Device Name | DOUBLE ANTIBODY GLUCAGON |
| Applicant | Diagnostic Products Corp. |
| Product Code | JME · Clinical Chemistry |
| Decision Date | Oct 31, 1989 |
| 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.
