Cleared Special

SAS FLUALERT A & B, SAS INFLUENZA A TEST

K132352 · Sa Scientific , Ltd. · Microbiology
Aug 2013
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K132352 is an FDA 510(k) clearance for the SAS FLUALERT A & B, SAS INFLUENZA A TEST, a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I — General Controls, product code GNX), submitted by Sa Scientific , Ltd. (San Antonio, US). The FDA issued a Cleared decision on August 22, 2013, 24 days after receiving the submission on July 29, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K132352 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2013
Decision Date August 22, 2013
Days to Decision 24 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GNX — Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3330

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