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510(k) K240636

HemoScreen Hematology Analyzer by Pixcell Medical Technologies — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2024
Date Received
March 6, 2024
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Pixcell Medical Technologies

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  • K180020 — HemoScreen Hematology Analyzer (October 29, 2018)

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