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U.S. Department of Health and Human Services

510(k) Premarket Notification

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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name counter, differential cell
510(k) Number BK210639
Tradename Stem-Kit Reagents, stemCXP System
Device Name Counter, Differential Cell
Original Applicant
Beckman Coulter, Inc.
11800 sw 147 avenue
(m/c: 31-b06)
miami,  FL  33196 2500
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received11/15/2021
Decision Date 12/15/2021
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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