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FDA 510(k)

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA

K-Number: K163133 · 2017-08-08

ApplicantImmco Diagnostics, Inc.
Decision Date2017-08-08
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA is a medical device manufactured by Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-08-08 under approval number K163133. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA?

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by Immco Diagnostics, Inc.. The 510(k) number is K163133.

When was ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA approved by the FDA?

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA received FDA 510(k) clearance on 2017-08-08, under approval number K163133.

What company makes ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA?

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA is manufactured by Immco Diagnostics, Inc..

What is the FDA product code for ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA?

The FDA product code for ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA is DBM.

Other Devices by Immco Diagnostics, Inc.

K151559ImmuLisa Enhanced Centromere 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 K172745ImmuGlo HEp-2 Elite IFA K172078ImmuLisa Enhanced RNA POL III Antibody ELISA

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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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