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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 K162076
Device Name chromID MRSA
Applicant
Biomerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Applicant Contact Karen Russell
Correspondent
Biomerieux, Inc.
595 Anglum Rd.
Hazelwood,  MO  63042
Correspondent Contact Karen Russell
Regulation Number866.1700
Classification Product Code
JSO  
Date Received07/27/2016
Decision Date 10/25/2016
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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