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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
510(k) Number K143312
Device Name Portrait GBS Assay
Applicant
Great Basin Corporation
2441 S. 3850 W.
Salt Lake City,  UT  84120
Applicant Contact Chuck Owen
Correspondent
Great Basin Corporation
2441 S. 3850 W.
Salt Lake City,  UT  84120
Correspondent Contact Chuck Owen
Regulation Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
NSU  
Date Received11/18/2014
Decision Date 04/21/2015
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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