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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K192355
Device Name MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
Applicant
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact Elaine Duncan
Correspondent
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact Elaine Duncan
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Codes
LRG   LTT   LTW  
Date Received08/29/2019
Decision Date 11/14/2019
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
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