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FDA 510(k)

C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST

K-Number: K962019 · 1996-11-25

ApplicantTeco Diagnostics
Decision Date1996-11-25
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1996-11-25 under 510(k) number K962019. 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 C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST?

C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Teco Diagnostics. The 510(k) number is K962019.

When did C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST receive FDA 510(k) clearance?

C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST received FDA 510(k) clearance on 1996-11-25, under 510(k) number K962019.

Who is the listed applicant for C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST?

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

What is the FDA product code for C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST?

The FDA product code for C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST is DCK.

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Other records listing Teco Diagnostics 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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