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FDA 510(k)

HUMAN IGD KIT FOR USE ON SPAPLUS

K-Number: K092450 · 2009-12-28

ApplicantThe Binding Site
Decision Date2009-12-28
Product CodeCZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN IGD KIT FOR USE ON SPAPLUS 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 2009-12-28 under 510(k) number K092450. The device is classified under product code CZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN IGD KIT FOR USE ON SPAPLUS?

HUMAN IGD KIT FOR USE ON SPAPLUS is a medical device that received FDA 510(k) clearance on 2009-12-28. The listed applicant is The Binding Site. The 510(k) number is K092450.

When did HUMAN IGD KIT FOR USE ON SPAPLUS receive FDA 510(k) clearance?

HUMAN IGD KIT FOR USE ON SPAPLUS received FDA 510(k) clearance on 2009-12-28, under 510(k) number K092450.

Who is the listed applicant for HUMAN IGD KIT FOR USE ON SPAPLUS?

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 HUMAN IGD KIT FOR USE ON SPAPLUS?

The FDA product code for HUMAN IGD KIT FOR USE ON SPAPLUS is CZJ.

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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 ANALYZERK072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERK042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITK042152BINDING SITE IGG SUBLCASS OLYMPUS KITS

View all 9 devices →

Related Devices (Code: CZJ)

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.

K051299IGD DIAGNOSTIC TEST KITSThe Binding Site, Ltd.K002561SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KITThe Binding Site, Ltd.K913671HUMAN IGD IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K883001QM300 CALIBRATOR D PACKKallestad Diag, A Div. of Erbamont, Inc.K872834TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410Helena LaboratoriesK831956DETERM. SIZE 72 RADIAL-HUMAN IGDKent Laboratories, Inc.

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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