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)

RDI HS CRP KIT

K-Number: K021609 · 2002-06-27

ApplicantReference Diagnostics, Inc.
Decision Date2002-06-27
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RDI HS CRP KIT is the device name listed in this FDA 510(k) record. The listed applicant is Reference Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-06-27 under 510(k) number K021609. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RDI HS CRP KIT?

RDI HS CRP KIT is a medical device that received FDA 510(k) clearance on 2002-06-27. The listed applicant is Reference Diagnostics, Inc.. The 510(k) number is K021609.

When did RDI HS CRP KIT receive FDA 510(k) clearance?

RDI HS CRP KIT received FDA 510(k) clearance on 2002-06-27, under 510(k) number K021609.

Who is the listed applicant for RDI HS CRP KIT?

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

What is the FDA product code for RDI HS CRP KIT?

The FDA product code for RDI HS CRP KIT is DCK.

Other records listing Reference Diagnostics, Inc. 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.

K053211RDI HSFERRITIN KITK053291FERRITIN CALIBRATOR SET, CATALOG NO. 8203K052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETK030044EXTENDED RANGE HS CRP KIT, CAT NO:9200K030772RDI EXTENDED RANGE CRP CALIBRATOR SETK021607RDI HS CRP CALIBRATOR SET

View all 17 devices →

Related Devices (Code: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

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.

↑