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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device creatinine test system for at home prescription use
Regulation Description Creatinine test system.
Definition For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. This device is for prescription use only.
Product CodeSHB
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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