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FDA 510(k)

FISHER DIAGNOSTICS LATEST-CRP TEST KIT

K-Number: K850160 · 1985-04-19

ApplicantFisher Diagnostics
Decision Date1985-04-19
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FISHER DIAGNOSTICS LATEST-CRP TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 1985-04-19 under 510(k) number K850160. 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 FISHER DIAGNOSTICS LATEST-CRP TEST KIT?

FISHER DIAGNOSTICS LATEST-CRP TEST KIT is a medical device that received FDA 510(k) clearance on 1985-04-19. The listed applicant is Fisher Diagnostics. The 510(k) number is K850160.

When did FISHER DIAGNOSTICS LATEST-CRP TEST KIT receive FDA 510(k) clearance?

FISHER DIAGNOSTICS LATEST-CRP TEST KIT received FDA 510(k) clearance on 1985-04-19, under 510(k) number K850160.

Who is the listed applicant for FISHER DIAGNOSTICS LATEST-CRP TEST KIT?

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

What is the FDA product code for FISHER DIAGNOSTICS LATEST-CRP TEST KIT?

The FDA product code for FISHER DIAGNOSTICS LATEST-CRP TEST KIT is DCK.

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Other records listing Fisher Diagnostics 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.

K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsK070640ARCHITECT STAT TROPONIN-1; MYOGLOBINK052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSK052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMK042924ARCHITECT STAT MYO IMMUNOASSAYK041192ARCHITECT STAT TROPONIN-I IMMUNOASSAY

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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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