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FDA 510(k)

IGD DIAGNOSTIC TEST KITS

K-Number: K051299 · 2005-11-23

ApplicantThe Binding Site, Ltd.
Decision Date2005-11-23
Product CodeCZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGD DIAGNOSTIC TEST KITS 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 2005-11-23 under 510(k) number K051299. 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 IGD DIAGNOSTIC TEST KITS?

IGD DIAGNOSTIC TEST KITS is a medical device that received FDA 510(k) clearance on 2005-11-23. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K051299.

When did IGD DIAGNOSTIC TEST KITS receive FDA 510(k) clearance?

IGD DIAGNOSTIC TEST KITS received FDA 510(k) clearance on 2005-11-23, under 510(k) number K051299.

Who is the listed applicant for IGD DIAGNOSTIC TEST KITS?

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 IGD DIAGNOSTIC TEST KITS?

The FDA product code for IGD DIAGNOSTIC TEST KITS is CZJ.

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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)

View all 115 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.

K092450HUMAN IGD KIT FOR USE ON SPAPLUSThe Binding SiteK002561SHEEP 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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