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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 26
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
PHARMACIA & UPJOHN CO.
  SUBSTANTIALLY EQUIVALENT 6
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 9
SIEMENS
  SUBSTANTIALLY EQUIVALENT 5
VENTREX, INC.
  SUBSTANTIALLY EQUIVALENT 2

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 2 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hitachi Chemical Diagnostics Inc III Feb-07-2013
2 Phadia US Inc II Jan-12-2015
3 Siemens Healthcare Diagnostics, Inc. II Jun-25-2015

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