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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent/Device, Inoculum Calibration
510(k) Number K221493
Device Name MicroScan Prompt Inoculation System-D
Applicant
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact Sharon Cullen
Correspondent
Beckman Coulter, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact Sharon Cullen
Regulation Number866.1640
Classification Product Code
LIE  
Date Received05/23/2022
Decision Date 04/05/2023
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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