ENZYMUN TEST(R) INSULIN
Device Facts
| Record ID | K901135 |
|---|---|
| Device Name | ENZYMUN TEST(R) INSULIN |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | CFP · Clinical Chemistry |
| Decision Date | Apr 3, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1405 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.
