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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
510(k) Number K172412
Device Name BacterioScan 216Dx System
Applicant
Bacterioscan, Inc.
4041 Forest Park Ave.
Saint Louis,  MO  63108
Applicant Contact Rhonda Soest
Correspondent
MDC Associates, LLC
180 Cabot St.
Beverly,  MA  01915
Correspondent Contact Fran White
Regulation Number866.2560
Classification Product Code
QBQ  
Date Received08/10/2017
Decision Date 05/01/2018
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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