← Product Code [JKD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD) · K854066

# DOUBLE ANTIBODY C-PEPTIDE RIA KIT (K854066)

_Diagnostic Products Corp. · JKD · Nov 12, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K854066

## Device Facts

- **Applicant:** Diagnostic Products Corp.
- **Product Code:** [JKD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD.md)
- **Decision Date:** Nov 12, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1135
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K854066](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKD/K854066)

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