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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, methadone
Product CodeDJR
Regulation Number 862.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
ARK DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIN-ZHI INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
LIN-ZHI INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego Inc. DBA Immunalysis Corporation III Jun-08-2018
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