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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
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
BODITECH MED INC.
  SUBSTANTIALLY EQUIVALENT 1
EIKEN CHEMICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
IMMUNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.H.P.M., INC
  SUBSTANTIALLY EQUIVALENT 1

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