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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, glycosylated hemoglobin
Regulation Description Glycosylated hemoglobin assay.
Product CodeLCP
Regulation Number 864.7470
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 8
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 15
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
KULZER
  SUBSTANTIALLY EQUIVALENT 4
LXN CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 10
SIEMENS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2

Device Problems
High test results 15
Low test results 1
Total Device Problems 16

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 2 2 4 4 1 0
Class III 0 0 0 1 5 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alfa Wassermann, Inc. II Dec-17-2008
2 Beckman Coulter Inc. II May-10-2011
3 Bio-Rad Laboratories Inc III Jul-27-2011
4 Bio-Rad Laboratories Inc II Apr-11-2011
5 Bio-Rad Laboratories Inc II Apr-06-2011
6 Bio-Rad Laboratories Inc III Feb-17-2011
7 Bio-Rad Laboratories Inc II Feb-15-2011
8 Bio-Rad Laboratories Inc II Oct-22-2010
9 Bio-Rad Laboratories Inc II Oct-21-2010
10 Bio-Rad Laboratories Inc II Jun-25-2010
11 Bio-Rad Laboratories Inc III Mar-05-2010
12 Bio-Rad Laboratories Inc II Feb-26-2010
13 Bio-Rad Laboratories Inc II May-19-2009
14 Bio-Rad Laboratories Inc II Mar-24-2009
15 Bio-Rad Laboratories, Inc. III Oct-07-2011
16 Bio-Rad Laboratories, Inc. III Sep-06-2011
17 Bio-Rad Laboratories, Inc., Hercules, CA III Apr-13-2011
18 Cholestech Corp II Sep-23-2008
19 Heritage Labs International LLC II Jan-11-2012

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