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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device acid, alpha-ketobutyric and nadh (u.v.), hydroxybutyric dehydrogenase
Regulation Description Hydroxybutyric dehydrogenase test system.
Product CodeJMK
Regulation Number 862.1380
Device Class 1


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1

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