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FDA 510(k)

RHEUMAGEN CRP T-CONTROL

K-Number: K904312 · 1990-10-01

ApplicantBiokit USA, Inc.
Decision Date1990-10-01
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMAGEN CRP T-CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Biokit USA, Inc.. It received FDA 510(k) clearance on 1990-10-01 under 510(k) number K904312. 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 RHEUMAGEN CRP T-CONTROL?

RHEUMAGEN CRP T-CONTROL is a medical device that received FDA 510(k) clearance on 1990-10-01. The listed applicant is Biokit USA, Inc.. The 510(k) number is K904312.

When did RHEUMAGEN CRP T-CONTROL receive FDA 510(k) clearance?

RHEUMAGEN CRP T-CONTROL received FDA 510(k) clearance on 1990-10-01, under 510(k) number K904312.

Who is the listed applicant for RHEUMAGEN CRP T-CONTROL?

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

What is the FDA product code for RHEUMAGEN CRP T-CONTROL?

The FDA product code for RHEUMAGEN CRP T-CONTROL is DCK.

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Other records listing Biokit USA, 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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