FDA 510(k)

IGE EIA TEST KIT

K-Number: K920087 · 1992-09-14

Decision Date1992-09-14

Product CodeDGO

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

IGE EIA TEST KIT 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 1992-09-14 under 510(k) number K920087. The device is classified under product code DGO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGE EIA TEST KIT?

IGE EIA TEST KIT is a medical device that received FDA 510(k) clearance on 1992-09-14. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K920087.

When did IGE EIA TEST KIT receive FDA 510(k) clearance?

IGE EIA TEST KIT received FDA 510(k) clearance on 1992-09-14, under 510(k) number K920087.

Who is the listed applicant for IGE EIA TEST KIT?

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 IGE EIA TEST KIT?

The FDA product code for IGE EIA TEST KIT is DGO.

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 Kit K090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K083289HUMAN BETA-2 MICROGLOBULIN KIT K082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER K081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS K081674BINDAZYME 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: DGO)

K943194IMMULITE(R) ALLERGY FOOD PANEL FP5EDiagnostic Products Corp.K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIEDDiagnostic Products Corp.K894039QUIDEL TOTAL IGE TEST QUANTITATIVE VERSIONQuidel Corp.K893125BECKMAN EPSILON(TM) IGE REAGENT KITBeckman Instruments, Inc.K872801ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5Diagnostic Products Corp.K860851ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEMNichols Institute Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.