REP(TM) SPE PLUS-30 PROCEDURES
Device Facts
| Record ID | K896572 |
|---|---|
| Device Name | REP(TM) SPE PLUS-30 PROCEDURES |
| Applicant | Helena Laboratories |
| Product Code | CFP · Clinical Chemistry |
| Decision Date | Jan 11, 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.
