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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
510(k) Number K171061
Device Name MRSASelect II
Applicant
Bio-Rad
3 Blvd. Raymond Poincare
92430 Marnes-La-Coquette,  FR 92430
Applicant Contact Sylvie Fernez
Correspondent
MDC Associates, LLC
180 Cabot St.,
Beverly,  MA  01915
Correspondent Contact Fran White
Regulation Number866.1700
Classification Product Code
JSO  
Date Received04/10/2017
Decision Date 12/28/2017
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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