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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device colorimetric method, gamma-glutamyl transpeptidase
Regulation Description Gamma-glutamyl transpeptidase and isoenzymes test system.
Product CodeJPZ
Regulation Number 862.1360
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 1

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