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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device capillary blood collection device for alternative site collection
Definition A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes.
Product CodePRJ
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
SEVENTH SENSE BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

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