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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device automated multicolor fluorescent imaging cytometric analysis system
Regulation Description Automated differential cell counter.
Definition An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.g., hemoglobin) using spectrophotometric absorbance measurement and fluorescence measurements.
Product CodePMG
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K150815  BD FACSPresto System, BD FACSPresto CD4/Hb Cartrid ...

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