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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
  1.  K012656  LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, ...
  2.  K021498  LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3 ...
  3.  K903430  LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2
  4.  K925151  LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
  5.  K961828  LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,68 ...
  6.  K980556  LIQUICHEK CARDIAC MARKERS CONTROL LT
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
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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