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FDA 510(k)

ImmuLisa Enhanced RNA POL III Antibody ELISA

K-Number: K172078 · 2018-03-30

ApplicantImmco Diagnostics, Inc.
Decision Date2018-03-30
Product CodeNYO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ImmuLisa Enhanced RNA POL III Antibody ELISA is a medical device manufactured by Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-03-30 under approval number K172078. The device is classified under product code NYO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImmuLisa Enhanced RNA POL III Antibody ELISA?

ImmuLisa Enhanced RNA POL III Antibody ELISA is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Immco Diagnostics, Inc.. The 510(k) number is K172078.

When was ImmuLisa Enhanced RNA POL III Antibody ELISA approved by the FDA?

ImmuLisa Enhanced RNA POL III Antibody ELISA received FDA 510(k) clearance on 2018-03-30, under approval number K172078.

What company makes ImmuLisa Enhanced RNA POL III Antibody ELISA?

ImmuLisa Enhanced RNA POL III Antibody ELISA is manufactured by Immco Diagnostics, Inc..

What is the FDA product code for ImmuLisa Enhanced RNA POL III Antibody ELISA?

The FDA product code for ImmuLisa Enhanced RNA POL III Antibody ELISA is NYO.

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 K172745ImmuGlo HEp-2 Elite IFA

Related Devices (Code: NYO)

K202541EliA RNA Pol IIIPhadia AB

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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