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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
Regulation Description Automated cell-locating device.
Product CodeJOY
Regulation Number 864.5260
Device Class 2


Premarket Reviews
ManufacturerDecision
SYSMEX
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Display or Visual Feedback Problem 4
Patient Data Problem 2
Adverse Event Without Identified Device or Use Problem 2
Total Device Problems 8

Recalls
Manufacturer Recall Class Date Posted
1 Cellavision AB II Jun-13-2018
2 Leica Biosystems Richmond Inc. III Jun-20-2016
3 Roche Diagnostics Hematology II Jul-26-2018

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