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FDA 510(k)

OSOM INFLUENZA A&B TEST MODEL 190

K-Number: K123182 · 2012-11-05

ApplicantSEKISUI Diagnostics, LLC
Decision Date2012-11-05
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OSOM INFLUENZA A&B TEST MODEL 190 is the device name listed in this FDA 510(k) record. The listed applicant is SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2012-11-05 under 510(k) number K123182. The device is classified under product code GNX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSOM INFLUENZA A&B TEST MODEL 190?

OSOM INFLUENZA A&B TEST MODEL 190 is a medical device that received FDA 510(k) clearance on 2012-11-05. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K123182.

When did OSOM INFLUENZA A&B TEST MODEL 190 receive FDA 510(k) clearance?

OSOM INFLUENZA A&B TEST MODEL 190 received FDA 510(k) clearance on 2012-11-05, under 510(k) number K123182.

Who is the listed applicant for OSOM INFLUENZA A&B TEST MODEL 190?

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

What is the FDA product code for OSOM INFLUENZA A&B TEST MODEL 190?

The FDA product code for OSOM INFLUENZA A&B TEST MODEL 190 is GNX.

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Other records listing SEKISUI Diagnostics, LLC 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.

K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemK192719Osom Ultra Plus Flu A&B Test KitK182001Acucy Influenza A&B Test with the Acucy SystemK181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestK121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT

Related Devices (Code: GNX)

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.

K133411ALERE BINAXNOW INFLUENZA A & B CARDAlere Scarborough, Inc D/B/A Binax, Inc.K132352SAS FLUALERT A & B, SAS INFLUENZA A TESTSa Scientific , Ltd.K131804REMEL XPECT FLU A&BRemel, Inc.K131599QUICK VUE INFLUENZAQuidel CorporationK131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131619QUICKVUE INFLUENZA A+BQuidel Corp.

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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