Great Basin Shiga Toxin Direct Test— 510(k) K152955

Name: FDA 510(k) clearance K152955
Creator: U.S. Food and Drug Administration
Published: 2016-03-22

Substantially Equivalent

Great Basin Scientific, Inc.

FDA 510(k) clearance K152955 for Great Basin Shiga Toxin Direct Test, Substantially Equivalent on 2016-03-22. Applicant: Great Basin Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Great Basin Scientific, Inc.
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2015-10-07
Decision date: 2016-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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