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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme controls (assayed and unassayed)
Regulation Description Quality control material (assayed and unassayed).
Product CodeJJT
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 6
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
  1.  K971777  QUANTEX ASO-CRP-RF CONTROL
  2.  K984437  QUANTEX ASO-CRP-RP CONTROL II
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. III Nov-02-2012

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