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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent/device, inoculum calibration
Product CodeLIE
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-06-2020
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