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FDA 510(k)

ALLERG-E IGE ENZYME IMMUNOASSAY KIT

K-Number: K853607 · 1985-11-07

ApplicantDexall Biomedical Labs, Inc.
Decision Date1985-11-07
Product CodeDGO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALLERG-E IGE ENZYME IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dexall Biomedical Labs, Inc.. It received FDA 510(k) clearance on 1985-11-07 under 510(k) number K853607. 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 ALLERG-E IGE ENZYME IMMUNOASSAY KIT?

ALLERG-E IGE ENZYME IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1985-11-07. The listed applicant is Dexall Biomedical Labs, Inc.. The 510(k) number is K853607.

When did ALLERG-E IGE ENZYME IMMUNOASSAY KIT receive FDA 510(k) clearance?

ALLERG-E IGE ENZYME IMMUNOASSAY KIT received FDA 510(k) clearance on 1985-11-07, under 510(k) number K853607.

Who is the listed applicant for ALLERG-E IGE ENZYME IMMUNOASSAY KIT?

The FDA 510(k) record lists Dexall Biomedical Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLERG-E IGE ENZYME IMMUNOASSAY KIT?

The FDA product code for ALLERG-E IGE ENZYME IMMUNOASSAY KIT is DGO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dexall Biomedical Labs, Inc. 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.

K885269ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENSK875066ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KITK864696ALLERG*ENS ENZYME IMMUNOASSAY KIT

Related Devices (Code: DGO)

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.

K943194IMMULITE(R) ALLERGY FOOD PANEL FP5EDiagnostic Products Corp.K920087IGE EIA TEST KITThe Binding Site, Ltd.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.

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.

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