C-PEP-RIA-100

FDA 510(k) K842267 · Institut National Des Radioelements

Substantially Equivalent

510(k) numberK842267

Submission

Device name
C-PEP-RIA-100
Applicant
Institut National Des Radioelements
Walker, MI, US
Received
June 8, 1984
Decision date
September 6, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JKD – Radioimmunoassay, C-Peptides Of Proinsulin
Device class
Class I (low risk)
Regulation
21 CFR 862.1135
Specialty
Clinical Chemistry

Other 510(k)s with product code JKD

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K951848Aia-Pack CPR AssayJKD · Traditional Tosoh Medics, Inc.02/13/1996SE
K943767Immulite C-PeptideJKD · Traditional Diagnostic Products Corp.03/23/1995SE
K896420DSL C-Peptide Ria (DSL #7000)JKD · Traditional Diagnostic Systems Laboratories, Inc.05/24/1990SE
K854066Double Antibody C-Peptide Ria KitJKD · Traditional Diagnostic Products Corp.11/12/1985SE
K833396C-Peptide Radioimmunoassay Test KitJKD · Traditional Serono Diagnostics, Inc.04/13/1984SE
K820666Human C-Peptide of Insulin by Radioimm.JKD · Traditional Immuno Nuclear Corp.07/13/1982SE
K812689Ria Quant C-Peptide KitJKD · Traditional Mallinckrodt Critical Care10/06/1981SE
K812288Human C-Peptide ReagentsJKD · Traditional Immunex Radiochemical Diagnostics08/31/1981SE
K810718C-Peptice ReagentsJKD · Traditional Calbiochem-Behring Corp.03/31/1981SE

More from Calbiochem-Behring Corp.

510(k)DeviceDecision
K791128PTH Ria 200CEW · Traditional 09/27/1979SE

Questions and answers

When was C-PEP-RIA-100 cleared by the FDA?

C-PEP-RIA-100 (K842267) received a 510(k) decision of Substantially Equivalent on September 6, 1984, 90 days after the submission was received.

What is the product code of K842267?

The FDA product code is JKD – Radioimmunoassay, C-Peptides Of Proinsulin, a Class I (low risk) device regulated under 21 CFR 862.1135.