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FDA 510(k)

JBAIDS INFLUENZA A SUBTYPING KIT

K-Number: K111778 · 2011-09-13

ApplicantU.S Army Medical Materiel Development Activity
Decision Date2011-09-13
Product CodeOQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

JBAIDS INFLUENZA A SUBTYPING KIT is the device name listed in this FDA 510(k) record. The listed applicant is U.S Army Medical Materiel Development Activity. It received FDA 510(k) clearance on 2011-09-13 under 510(k) number K111778. The device is classified under product code OQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JBAIDS INFLUENZA A SUBTYPING KIT?

JBAIDS INFLUENZA A SUBTYPING KIT is a medical device that received FDA 510(k) clearance on 2011-09-13. The listed applicant is U.S Army Medical Materiel Development Activity. The 510(k) number is K111778.

When did JBAIDS INFLUENZA A SUBTYPING KIT receive FDA 510(k) clearance?

JBAIDS INFLUENZA A SUBTYPING KIT received FDA 510(k) clearance on 2011-09-13, under 510(k) number K111778.

Who is the listed applicant for JBAIDS INFLUENZA A SUBTYPING KIT?

The FDA 510(k) record lists U.S Army Medical Materiel Development Activity as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JBAIDS INFLUENZA A SUBTYPING KIT?

The FDA product code for JBAIDS INFLUENZA A SUBTYPING KIT is OQW.

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Related Devices (Code: OQW)

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.

K132237PRODESSE PROFAST+ ASSAYGen-Probe Prodesse, Inc.K130551CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and PreventionK123905CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and PreventionK120911XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)CepheidK111507CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and PreventionK103766XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0Cepheid

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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