Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Icubate, Inc.. It received FDA 510(k) clearance on 2017-08-08 under 510(k) 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. The listed applicant is Icubate, Inc.. The 510(k) number is K163390.

When did iC-GPC Assay TM for use on the iC-SystemTM receive FDA 510(k) clearance?

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

Who is the listed applicant for iC-GPC Assay TM for use on the iC-SystemTM?

The FDA 510(k) record lists Icubate, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Icubate, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: PAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbHK243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex CorporationK181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelGenmark Diagnostics, IncorporatedK152470Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc.

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.

↑