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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 K193358
Device Name MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
Applicant
Beckman Coulter, Inc.
1584 Enterprise Blvd
West Sacramento,  CA  95630
Applicant Contact Elaine Duncan
Correspondent
Beckman Coulter, Inc.
1584 Enterprise Blvd
West Sacramento,  CA  95630
Correspondent Contact Elaine Duncan
Regulation Number866.1640
Classification Product Code
LTT  
Subsequent Product Codes
JWY   LRG   LTW  
Date Received12/04/2019
Decision Date 03/03/2020
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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