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FDA 510(k)

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

K-Number: K163390 · 2017-08-08

ApplicantIcubate, Inc.
Decision Date2017-08-08
Product CodePAM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

iC-GPC Assay TM for use on the iC-SystemTM is a medical device manufactured by Icubate, Inc.. It received FDA 510(k) clearance on 2017-08-08 under approval number K163390. The device is classified under product code PAM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iC-GPC Assay TM for use on the iC-SystemTM?

iC-GPC Assay TM for use on the iC-SystemTM is a medical device that received FDA 510(k) clearance on 2017-08-08. It is manufactured by Icubate, Inc.. The 510(k) number is K163390.

When was iC-GPC Assay TM for use on the iC-SystemTM approved by the FDA?

iC-GPC Assay TM for use on the iC-SystemTM received FDA 510(k) clearance on 2017-08-08, under approval number K163390.

What company makes iC-GPC Assay TM for use on the iC-SystemTM?

iC-GPC Assay TM for use on the iC-SystemTM is manufactured by Icubate, Inc..

What is the FDA product code for iC-GPC Assay TM for use on the iC-SystemTM?

The FDA product code for iC-GPC Assay TM for use on the iC-SystemTM is PAM.

Other Devices by Icubate, Inc.

K190341iC-GN iC-Cassette for use on the iC-System

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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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