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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acid phosphatase, naphthyl phosphate
Regulation Description Acid phosphatase (total or prostatic) test system.
Product CodeCKB
Regulation Number 862.1020
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

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