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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 K182467
Device Name Simplexa GBS Direct, Simplexa GBS Positive Control Pack
Applicant
Diasorin Molecular, LLC
11331 Valley View St.
Cypress,  CA  90630
Applicant Contact Sharon Young
Correspondent
Diasorin Molecular, LLC
11331 Valley View St.
Cypress,  CA  90630
Correspondent Contact Sharon Young
Regulation Number866.3740
Classification Product Code
NJR  
Subsequent Product Code
OOI  
Date Received09/10/2018
Decision Date 11/07/2018
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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