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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device indicator method, protein or albumin (urinary, non-quant.)
Regulation Description Urinary protein or albumin (nonquantitative) test system.
Product CodeJIR
Regulation Number 862.1645
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 4
  1.  K963142  DCA 2000 + MICROALBUMIN/CREATININE ASSAY
  2.  K982219  MICROALBUSTIX REAGENT STRIPS
  3.  K991315  MICROALBUSTIX REAGENT STRIPS (OTC)
  4.  K992257  NEW MULTIPLES REAGENT STRIPS
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False negative result 1
Total Device Problems 1

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