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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, automated cell locating, bone marrow
Definition An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type.
Product CodeSAL
Regulation Number 864.5261
Device Class 2


Premarket Reviews
ManufacturerDecision
SCOPIO LABS , LTD.
  GRANTED 1

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