HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
Device Facts
| Record ID | K820666 |
|---|---|
| Device Name | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. |
| Applicant | Immuno Nuclear Corp. |
| Product Code | JKD · Clinical Chemistry |
| Decision Date | Jul 13, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1135 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.
