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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device control, fecal occult blood
Regulation Description Occult blood test.
Definition Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
Product CodeOSL
Regulation Number 864.6550
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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