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FDA 510(k)

LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER

K-Number: K111387 · 2011-08-04

ApplicantIquum, Inc.
Decision Date2011-08-04
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Iquum, Inc.. It received FDA 510(k) clearance on 2011-08-04 under 510(k) number K111387. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER?

LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER is a medical device that received FDA 510(k) clearance on 2011-08-04. The listed applicant is Iquum, Inc.. The 510(k) number is K111387.

When did LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER receive FDA 510(k) clearance?

LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER received FDA 510(k) clearance on 2011-08-04, under 510(k) number K111387.

Who is the listed applicant for LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER?

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

What is the FDA product code for LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER?

The FDA product code for LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER is OCC.

Related Clinical Trials

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Other records listing Iquum, 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.

K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System

Related Devices (Code: OCC)

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.

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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