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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, radioallergosorbent (rast) immunological
Regulation Description Radioallergosorbent (RAST) immunological test system.
Product CodeDHB
Regulation Number 866.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 14
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 24
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
PHARMACIA & UPJOHN CO.
  SUBSTANTIALLY EQUIVALENT 6
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 9
SIEMENS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
VENTREX, INC.
  SUBSTANTIALLY EQUIVALENT 2

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 1

Recalls
Manufacturer Recall Class Date Posted
1 Hitachi Chemical Diagnostics Inc III Feb-07-2013

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