Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

C-PEP-RIA-100

K-Number: K842267 · 1984-09-06

ApplicantInstitut National Des Radioelements
Decision Date1984-09-06
Product CodeJKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

C-PEP-RIA-100 is the device name listed in this FDA 510(k) record. The listed applicant is Institut National Des Radioelements. It received FDA 510(k) clearance on 1984-09-06 under 510(k) number K842267. The device is classified under product code JKD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-PEP-RIA-100?

C-PEP-RIA-100 is a medical device that received FDA 510(k) clearance on 1984-09-06. The listed applicant is Institut National Des Radioelements. The 510(k) number is K842267.

When did C-PEP-RIA-100 receive FDA 510(k) clearance?

C-PEP-RIA-100 received FDA 510(k) clearance on 1984-09-06, under 510(k) number K842267.

Who is the listed applicant for C-PEP-RIA-100?

The FDA 510(k) record lists Institut National Des Radioelements as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-PEP-RIA-100?

The FDA product code for C-PEP-RIA-100 is JKD.

Other records listing Institut National Des Radioelements as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K791128PTH RIA 200

Related Devices (Code: JKD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K951848AIA-PACK CPR ASSAYTosoh Medics, Inc.K943767IMMULITE C-PEPTIDEDiagnostic Products Corp.K896420DSL C-PEPTIDE RIA (DSL #7000)Diagnostic Systems Laboratories, Inc.K854066DOUBLE ANTIBODY C-PEPTIDE RIA KITDiagnostic Products Corp.K833396C-PEPTIDE RADIOIMMUNOASSAY TEST KITSerono Diagnostics, Inc.K820666HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.Immuno Nuclear Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑