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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bordetella pertussis dna assay system
510(k) Number K170284
Device Name Great Basin Bordetella Direct Test
Applicant
GREAT BASIN SCIENTIFIC, INC.
2441 S. 3850 WEST
SUITE 100
salt lake city,  UT  84120
Applicant Contact suzette chance
Correspondent
GREAT BASIN SCIENTIFIC, INC.
2441 S. 3850 WEST
SUITE 100
salt lake city,  UT  84120
Correspondent Contact suzette chance
Regulation Number866.3980
Classification Product Code
OZZ  
Subsequent Product Code
OOI  
Date Received01/30/2017
Decision Date 03/31/2017
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
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