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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gram-positive bacteria and their resistance markers
510(k) Number K152470
Device Name Great Basin Staph ID/R Blood Culture Panel
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 Number866.3365
Classification Product Code
PAM  
Date Received08/31/2015
Decision Date 03/25/2016
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
Recalls CDRH Recalls
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