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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gastrointestinal pathogen panel multiplex nucleic acid-based assay system
510(k) Number K152955
Device Name Great Basin Shiga Toxin Direct Test
Applicant
GREAT BASIN SCIENTIFIC, INC.
2441 S. 3850 West
salt lake city,  UT  84120
Applicant Contact chuck owen
Correspondent
GREAT BASIN SCIENTIFIC, INC.
2441 S. 3850 West
salt lake city,  UT  84120
Correspondent Contact chuck owen
Regulation Number866.3990
Classification Product Code
PCH  
Date Received10/07/2015
Decision Date 03/22/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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