510(k) K062114

Device: CERULOPLASMIN, MODEL 2055953
Applicant: ROCHE DIAGNOSTICS CORP.
510(k) number: K062114
Product code: CHN
Decision: Substantially Equivalent (SESE)
Decision date: 2007-01-31
Date received: 2006-07-24
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: CORINA HARPER
Address: 9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

9610529
9610126
3006198300
3003795116
9610806

Source Documents#

510(k) summary PDF

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04015630928767	Ceruloplasmin	Roche Diagnostics GmbH	2016-09-20
04015630913589	Ceruloplasmin	Roche Diagnostics GmbH	2016-09-20
04015630906888	Tinaquant Ceruloplasmin	Roche Diagnostics GmbH	2016-09-20

Other 510(k) Records For Product Code CHN #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K091741	TINA-QUANT CERULOPLASMIN	Roche Diagnostics	2010-03-18
K063655	DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH	Dade Behring, Inc.	2007-02-15

Legacy Summary#

summary

FDA Review#

Decision Summary