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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device test, amphetamine, over the counter
Regulation Description Amphetamine test system.
Product CodeNFT
Regulation Number 862.3100
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVIN BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
AICHECK BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASSURE TECH., LLC
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU WONDFO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ALLTEST BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HANGZHOU CLONGENE BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALSTONE BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
QINGDAO HIGHTOP BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIVACHEK BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
WEBEST BIOTECH,, LLC
  SUBSTANTIALLY EQUIVALENT 1

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