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FDA 510(k)

iC-GN iC-Cassette for use on the iC-System

K-Number: K190341 · 2019-06-28

ApplicantIcubate, Inc.
Decision Date2019-06-28
Product CodePEN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

iC-GN iC-Cassette for use on the iC-System is a medical device manufactured by Icubate, Inc.. It received FDA 510(k) clearance on 2019-06-28 under approval number K190341. The device is classified under product code PEN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iC-GN iC-Cassette for use on the iC-System?

iC-GN iC-Cassette for use on the iC-System is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Icubate, Inc.. The 510(k) number is K190341.

When was iC-GN iC-Cassette for use on the iC-System approved by the FDA?

iC-GN iC-Cassette for use on the iC-System received FDA 510(k) clearance on 2019-06-28, under approval number K190341.

What company makes iC-GN iC-Cassette for use on the iC-System?

iC-GN iC-Cassette for use on the iC-System is manufactured by Icubate, Inc..

What is the FDA product code for iC-GN iC-Cassette for use on the iC-System?

The FDA product code for iC-GN iC-Cassette for use on the iC-System is PEN.

Other Devices by Icubate, Inc.

K163390iC-GPC Assay TM for use on the iC-SystemTM

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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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