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FDA 510(k)

HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER

K-Number: K080384 · 2008-06-06

ApplicantThe Binding Site, Ltd.
Decision Date2008-06-06
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER 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 2008-06-06 under 510(k) number K080384. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER?

HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER is a medical device that received FDA 510(k) clearance on 2008-06-06. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K080384.

When did HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER receive FDA 510(k) clearance?

HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER received FDA 510(k) clearance on 2008-06-06, under 510(k) number K080384.

Who is the listed applicant for HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER?

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 CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER?

The FDA product code for HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER is NDY.

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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: NDY)

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.

K242585Cystatin CSENTINEL CH. SpAK181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbHK161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)K111664DIAZYME CYSTATIN C POC TEST KITDiazyme LaboratoriesK093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLKamiya Biomedical Co.

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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