ALPCO/MERCODIA INSULIN ELISA
Device Facts
| Record ID | K963911 |
|---|---|
| Device Name | ALPCO/MERCODIA INSULIN ELISA |
| Applicant | American Laboratory Products Co., Ltd. |
| Product Code | CFP · Clinical Chemistry |
| Decision Date | Nov 1, 1996 |
| 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.
