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510(k) K091741

Device
TINA-QUANT CERULOPLASMIN
Applicant
Roche Diagnostics
510(k) number
K091741
Product code
CHN  
Decision
Substantially Equivalent (SESE)
Decision date
2010-03-18
Date received
2009-06-16
Regulation
866.5210
Classification name
Immunochemical, Ceruloplasmin
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHIE J GOODWIN
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CHN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K063655DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGHDade Behring, Inc.2007-02-15
K062114CERULOPLASMIN, MODEL 2055953Roche Diagnostics Corp.2007-01-31

Legacy Summary#

summary

FDA Review#

Decision Summary