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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K163571
Device Name Great Basin Stool Bacterial Pathogens Panel
Applicant
Great Basin Scientific, Inc.
2441 S. 3850 W.
Salt Lake City,  UT  84120
Applicant Contact Suzette Chance
Correspondent
Great Basin Scientific, Inc.
2441 S. 3850 W.
Salt Lake City,  UT  84120
Correspondent Contact Suzette Chance
Regulation Number866.3990
Classification Product Code
PCI  
Subsequent Product Code
PCH  
Date Received12/19/2016
Decision Date 07/12/2017
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
Predetermined Change
Control Plan Authorized		 No
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