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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device automated pipetting, diluting and specimen processing workstations for flow cytometric analysis
Regulation Description Pipetting and diluting system for clinical use.
Definition Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.
Product CodePER
Regulation Number 862.2750
Device Class 1


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to sense 2
Device operates differently than expected 2
Fitting problem 1
Total Device Problems 5

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