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FDA 510(k)

CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER

K-Number: K072166 · 2008-01-24

ApplicantThe Binding Site
Decision Date2008-01-24
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site. It received FDA 510(k) clearance on 2008-01-24 under 510(k) number K072166. 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 CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER?

CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER is a medical device that received FDA 510(k) clearance on 2008-01-24. The listed applicant is The Binding Site. The 510(k) number is K072166.

When did CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER receive FDA 510(k) clearance?

CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER received FDA 510(k) clearance on 2008-01-24, under 510(k) number K072166.

Who is the listed applicant for CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER?

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

What is the FDA product code for CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER?

The FDA product code for CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER is NDY.

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Other records listing The Binding Site 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.

K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITK103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSK100455SPAPLUS ANALYZERK092450HUMAN IGD KIT FOR USE ON SPAPLUSK042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITK042152BINDING SITE IGG SUBLCASS OLYMPUS KITS

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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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