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FDA 510(k)

TIA CRP TEST KIT

K-Number: K914155 · 1992-01-15

ApplicantCrestat Diagnostics, Inc.
Decision Date1992-01-15
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TIA CRP TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Crestat Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-01-15 under 510(k) number K914155. 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 TIA CRP TEST KIT?

TIA CRP TEST KIT is a medical device that received FDA 510(k) clearance on 1992-01-15. The listed applicant is Crestat Diagnostics, Inc.. The 510(k) number is K914155.

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

TIA CRP TEST KIT received FDA 510(k) clearance on 1992-01-15, under 510(k) number K914155.

Who is the listed applicant for TIA CRP TEST KIT?

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

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

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

Other records listing Crestat 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.

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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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