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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mixture, hematology quality control
Regulation Description Hematology quality control mixture.
Product CodeJPK
Regulation Number 864.8625
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 10
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Unknown (for use when the device problem is not known) 12
Total Device Problems 12

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 1 0 0 0 0 1 0 0
Class III 0 0 0 0 0 3 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Diagnostic Solutions II Apr-09-2014
2 Clinical Diagnostic Solutions III Nov-05-2012
3 Clinical Diagnostic Solutions III Nov-02-2012
4 Horiba Instruments, Inc dba Horiba Medical III Nov-21-2012
5 Quantimetrix Corporation II Jan-17-2009

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