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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name flow cytometric reagents and accessories.
510(k) Number BK230961
Tradenames AQUIOS CL Flow Cytometer, AQUIOS STEM Kit
Device Name Flow Cytometric Reagents and Accessories
Original Applicant
Beckman Coulter, Inc.
11800 sw 147 avenue
(m/c: 31-b06)
miami,  FL  33196 2500
Regulation Number864.5220
Classification Product Code
OYE  
Secondary Product Code
GKZ 
Date Received06/05/2023
Decision Date 09/01/2023
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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