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FDA 510(k)

ImmuLisa Enhanced Centromere Antibody ELISA

K-Number: K151559 · 2016-03-11

ApplicantImmco Diagnostics, Inc.
Decision Date2016-03-11
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ImmuLisa Enhanced Centromere Antibody ELISA is a medical device manufactured by Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-03-11 under approval number K151559. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImmuLisa Enhanced Centromere Antibody ELISA?

ImmuLisa Enhanced Centromere Antibody ELISA is a medical device that received FDA 510(k) clearance on 2016-03-11. It is manufactured by Immco Diagnostics, Inc.. The 510(k) number is K151559.

When was ImmuLisa Enhanced Centromere Antibody ELISA approved by the FDA?

ImmuLisa Enhanced Centromere Antibody ELISA received FDA 510(k) clearance on 2016-03-11, under approval number K151559.

What company makes ImmuLisa Enhanced Centromere Antibody ELISA?

ImmuLisa Enhanced Centromere Antibody ELISA is manufactured by Immco Diagnostics, Inc..

What is the FDA product code for ImmuLisa Enhanced Centromere Antibody ELISA?

The FDA product code for ImmuLisa Enhanced Centromere Antibody ELISA is LJM.

Other Devices by Immco Diagnostics, Inc.

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

Related Devices (Code: LJM)

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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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