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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device automated occult blood analyzer
Regulation Description Occult blood test.
Definition The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.
Product CodeOOX
Regulation Number 864.6550
Device Class 2


Premarket Reviews
ManufacturerDecision
W.H.P.M., INC.
  SUBSTANTIALLY EQUIVALENT 1

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