Great Basin Stool Bacterial Pathogens Panel

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System

Great Basin Scientific, Inc.

The following data is part of a premarket notification filed by Great Basin Scientific, Inc. with the FDA for Great Basin Stool Bacterial Pathogens Panel.

Pre-market Notification Details

Device IDK163571
510k NumberK163571
Device Name:Great Basin Stool Bacterial Pathogens Panel
ClassificationGastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Applicant Great Basin Scientific, Inc. 2441 S. 3850 West Salt Lake City,  UT  84120
ContactSuzette Chance
CorrespondentSuzette Chance
Great Basin Scientific, Inc. 2441 S. 3850 West Salt Lake City,  UT  84120
Product CodePCI  
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-19
Decision Date2017-07-12
Summary:summary

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