JKD · Radioimmunoassay, C-Peptides Of Proinsulin
Clinical Chemistry · 21 CFR 862.1135 · Class 1
Overview
| Product Code | JKD |
|---|---|
| Device Name | Radioimmunoassay, C-Peptides Of Proinsulin |
| Regulation | 21 CFR 862.1135 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K951848 | AIA-PACK CPR ASSAY | Tosoh Medics, Inc. | Feb 13, 1996 | SESE |
| K943767 | IMMULITE C-PEPTIDE | Diagnostic Products Corp. | Mar 23, 1995 | SESE |
| K896420 | DSL C-PEPTIDE RIA (DSL #7000) | Diagnostic Systems Laboratories, Inc. | May 24, 1990 | SESE |
| K854066 | DOUBLE ANTIBODY C-PEPTIDE RIA KIT | Diagnostic Products Corp. | Nov 12, 1985 | SESE |
| K842267 | C-PEP-RIA-100 | Institut National Des Radioelements | Sep 6, 1984 | SESE |
| K833396 | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | Apr 13, 1984 | SESE |
| K820666 | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. | Immuno Nuclear Corp. | Jul 13, 1982 | SESE |
| K812689 | RIA QUANT C-PEPTIDE KIT | Mallinckrodt Critical Care | Oct 6, 1981 | SESE |
| K812288 | HUMAN C-PEPTIDE REAGENTS | Immunex Radiochemical Diagnostics | Aug 31, 1981 | SESE |
| K810718 | C-PEPTICE REAGENTS | Calbiochem-Behring Corp. | Mar 31, 1981 | SESE |
Top Applicants
- Diagnostic Products Corp. — 2 clearances
- Calbiochem-Behring Corp. — 1 clearance
- Diagnostic Systems Laboratories, Inc. — 1 clearance
- Immunex Radiochemical Diagnostics — 1 clearance
- Immuno Nuclear Corp. — 1 clearance
