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)

HUMAN C-PEPTIDE REAGENTS

K-Number: K812288 · 1981-08-31

ApplicantImmunex Radiochemical Diagnostics
Decision Date1981-08-31
Product CodeJKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN C-PEPTIDE REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Immunex Radiochemical Diagnostics. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812288. 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 HUMAN C-PEPTIDE REAGENTS?

HUMAN C-PEPTIDE REAGENTS is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Immunex Radiochemical Diagnostics. The 510(k) number is K812288.

When did HUMAN C-PEPTIDE REAGENTS receive FDA 510(k) clearance?

HUMAN C-PEPTIDE REAGENTS received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812288.

Who is the listed applicant for HUMAN C-PEPTIDE REAGENTS?

The FDA 510(k) record lists Immunex Radiochemical Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAN C-PEPTIDE REAGENTS?

The FDA product code for HUMAN C-PEPTIDE REAGENTS is JKD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.K842267C-PEP-RIA-100Institut National Des RadioelementsK833396C-PEPTIDE RADIOIMMUNOASSAY TEST KITSerono Diagnostics, Inc.

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.

↑