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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Panels, Test, Susceptibility, Antimicrobial
510(k) Number K183127
Device Name MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
Applicant
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact Elaine Marie Duncan
Correspondent
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact Elaine Marie Duncan
Regulation Number866.1640
Classification Product Code
LTT  
Subsequent Product Codes
JWY   LRG   LTW  
Date Received11/13/2018
Decision Date 02/12/2019
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
Predetermined Change
Control Plan Authorized		 No
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