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FDA 510(k)

EXTENDED RANGE HS CRP KIT, CAT NO:9200

K-Number: K030044 · 2003-09-30

ApplicantReference Diagnostics, Inc.
Decision Date2003-09-30
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EXTENDED RANGE HS CRP KIT, CAT NO:9200 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 2003-09-30 under 510(k) number K030044. 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 EXTENDED RANGE HS CRP KIT, CAT NO:9200?

EXTENDED RANGE HS CRP KIT, CAT NO:9200 is a medical device that received FDA 510(k) clearance on 2003-09-30. The listed applicant is Reference Diagnostics, Inc.. The 510(k) number is K030044.

When did EXTENDED RANGE HS CRP KIT, CAT NO:9200 receive FDA 510(k) clearance?

EXTENDED RANGE HS CRP KIT, CAT NO:9200 received FDA 510(k) clearance on 2003-09-30, under 510(k) number K030044.

Who is the listed applicant for EXTENDED RANGE HS CRP KIT, CAT NO:9200?

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 EXTENDED RANGE HS CRP KIT, CAT NO:9200?

The FDA product code for EXTENDED RANGE HS CRP KIT, CAT NO:9200 is DCK.

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Other records listing Reference Diagnostics, Inc. as applicant

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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.

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