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FDA 510(k)

SAS FLUALERT A & B, SAS INFLUENZA A TEST

K-Number: K132352 · 2013-08-22

ApplicantSa Scientific , Ltd.
Decision Date2013-08-22
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS FLUALERT A & B, SAS INFLUENZA A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sa Scientific , Ltd.. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K132352. 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 SAS FLUALERT A & B, SAS INFLUENZA A TEST?

SAS FLUALERT A & B, SAS INFLUENZA A TEST is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Sa Scientific , Ltd.. The 510(k) number is K132352.

When did SAS FLUALERT A & B, SAS INFLUENZA A TEST receive FDA 510(k) clearance?

SAS FLUALERT A & B, SAS INFLUENZA A TEST received FDA 510(k) clearance on 2013-08-22, under 510(k) number K132352.

Who is the listed applicant for SAS FLUALERT A & B, SAS INFLUENZA A TEST?

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

What is the FDA product code for SAS FLUALERT A & B, SAS INFLUENZA A TEST?

The FDA product code for SAS FLUALERT A & B, SAS INFLUENZA A TEST is GNX.

Related Clinical Trials

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.

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Other records listing Sa Scientific , Ltd. 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.

K061496SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

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.K131804REMEL XPECT FLU A&BRemel, Inc.K131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131599QUICK VUE INFLUENZAQuidel CorporationK131619QUICKVUE INFLUENZA A+BQuidel Corp.K123182OSOM INFLUENZA A&B TEST MODEL 190SEKISUI Diagnostics, LLC

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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