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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, serological, positive control
Product CodeMJX
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
AALTO SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics III Oct-25-2016
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