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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
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
  1.  K904752  CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
  2.  K932950  TINA-QUANT MICROALBUMIN
  3.  K954346  CHEMSTRIP MICRAL URINE TEST STRIPS
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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