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FDA 510(k)

ImmuGlo HEp-2 Elite IFA

K-Number: K172745 · 2018-06-05

ApplicantImmco Diagnostics, Inc.
Decision Date2018-06-05
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ImmuGlo HEp-2 Elite IFA is a medical device manufactured by Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-05 under approval number K172745. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImmuGlo HEp-2 Elite IFA?

ImmuGlo HEp-2 Elite IFA is a medical device that received FDA 510(k) clearance on 2018-06-05. It is manufactured by Immco Diagnostics, Inc.. The 510(k) number is K172745.

When was ImmuGlo HEp-2 Elite IFA approved by the FDA?

ImmuGlo HEp-2 Elite IFA received FDA 510(k) clearance on 2018-06-05, under approval number K172745.

What company makes ImmuGlo HEp-2 Elite IFA?

ImmuGlo HEp-2 Elite IFA is manufactured by Immco Diagnostics, Inc..

What is the FDA product code for ImmuGlo HEp-2 Elite IFA?

The FDA product code for ImmuGlo HEp-2 Elite IFA is DHN.

Other Devices by Immco Diagnostics, Inc.

K151559ImmuLisa Enhanced Centromere Antibody ELISA K163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA K163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA K162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA K172078ImmuLisa Enhanced RNA POL III Antibody ELISA

Related Devices (Code: DHN)

K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.Kg K160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd. K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, 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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