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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nitroprusside, ketones (urinary, non-quant.)
Regulation Description Ketones (nonquantitative) test system.
Product CodeJIN
Regulation Number 862.1435
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
  1.  K060768  PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM ...
  2.  K875029  ABBOTT BREATH ACETONE ANALYZER

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