Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device system, test, rheumatoid factor
Regulation Description Rheumatoid factor immunological test system.
Product CodeDHR
Regulation Number 866.5775
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 3
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 1
GAMMA
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
UNIPATH
  SUBSTANTIALLY EQUIVALENT 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Oct-01-2012
2 Beckman Coulter Inc. II Mar-08-2012
3 Beckman Coulter Inc. II Jul-27-2011
4 Beckman Coulter Inc. II Mar-22-2011
5 Ortho-Clinical Diagnostics II Jan-11-2012
6 Thera Test Laboratories, Inc. II May-14-2012

-
-