SAS FLUALERT A & B, SAS INFLUENZA A TEST— 510(k) K132352

Name: FDA 510(k) clearance K132352
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Substantially Equivalent

Sa Scientific , Ltd.

FDA 510(k) clearance K132352 for SAS FLUALERT A & B, SAS INFLUENZA A TEST, Substantially Equivalent on 2013-08-22. Applicant: Sa Scientific , Ltd.. Device class: 1.

Clearance details

Applicant: Sa Scientific , Ltd.
Product code: Code GNX
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 2013-07-29
Decision date: 2013-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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