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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic, carbon-dioxide
Regulation Description Bicarbonate/carbon dioxide test system.
Product CodeKHS
Regulation Number 862.1160
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 4
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 16
Total Device Problems 16

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