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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device column chromatography & color development, hydroxyproline
Regulation Description Hydroxyproline test system.
Product CodeJMM
Regulation Number 862.1400
Device Class 1


Premarket Reviews
ManufacturerDecision
BAYER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
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 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Immunodiagnostics Systems Ltd II Oct-10-2012
2 Roche Diagnostics Operations, Inc. II Jul-12-2013

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