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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, residual, wbc in leukoreduced blood
Regulation Description Hematology quality control mixture.
Definition CBER
Product CodeMZG
Regulation Number 864.8625
Device Class 2


Premarket Reviews
ManufacturerDecision
NANOENTEK, INC.
  SUBSTANTIALLY EQUIVALENT 1

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