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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tonometer (calibration and q.c. of blood-gas instruments), clinical
Regulation Description Quality control material (assayed and unassayed).
Product CodeLCH
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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