IMMULITE C-PEPTIDE
Device Facts
| Record ID | K943767 |
|---|---|
| Device Name | IMMULITE C-PEPTIDE |
| Applicant | Diagnostic Products Corp. |
| Product Code | JKD · Clinical Chemistry |
| Decision Date | Mar 23, 1995 |
| 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.
