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FDA 510(k)

HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)

K-Number: K953207 · 1995-08-01

ApplicantThe Binding Site, Ltd.
Decision Date1995-08-01
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 1995-08-01 under 510(k) number K953207. 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 HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)?

HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-08-01. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K953207.

When did HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) receive FDA 510(k) clearance?

HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) received FDA 510(k) clearance on 1995-08-01, under 510(k) number K953207.

Who is the listed applicant for HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)?

The FDA 510(k) record lists The Binding Site, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)?

The FDA product code for HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) is DCK.

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Other records listing The Binding Site, Ltd. 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.

K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitK090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K083289HUMAN BETA-2 MICROGLOBULIN KITK082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERK081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSK081674BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)

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Related Devices (Code: DCK)

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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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