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FDA 510(k)

FIAX CRP TEST KIT

K-Number: K832054 · 1983-08-26

ApplicantIntl. Diagnostic Technology
Decision Date1983-08-26
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FIAX CRP TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1983-08-26 under 510(k) number K832054. 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 FIAX CRP TEST KIT?

FIAX CRP TEST KIT is a medical device that received FDA 510(k) clearance on 1983-08-26. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K832054.

When did FIAX CRP TEST KIT receive FDA 510(k) clearance?

FIAX CRP TEST KIT received FDA 510(k) clearance on 1983-08-26, under 510(k) number K832054.

Who is the listed applicant for FIAX CRP TEST KIT?

The FDA 510(k) record lists Intl. Diagnostic Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIAX CRP TEST KIT?

The FDA product code for FIAX CRP TEST KIT is DCK.

Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KIT

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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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