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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acid, folic, radioimmunoassay
Regulation Description Folic acid test system.
Product CodeCGN
Regulation Number 862.1295
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 4
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 5
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2

Device Problems
Defective item 29
High test results 1
Total Device Problems 30

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 1 1 1 0 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-15-2009
2 Abbott Laboratories II Jul-11-2007
3 Abbott Laboratories, Inc II May-09-2007
4 Baxter Healthcare Corp. II Apr-29-2010
5 Beckman Coulter Inc II Sep-21-2008
6 Beckman Coulter Inc. II Oct-10-2012
7 Siemens Healthcare Diagnostics, Inc II Dec-11-2012

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