510(k) K070531

Device: ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER
Applicant: Thermo Fisher Scientific
510(k) number: K070531
Product code: CGZ
Decision: Substantially Equivalent (SESE)
Decision date: 2007-09-04
Date received: 2007-02-23
Regulation: 862.1170
Classification name: Electrode, Ion-specific, Chloride
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K182072	VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides	Ortho-Clinical Diagnostics, Inc.	2018-10-30
K170320	Alinity c ICT Sample Diluent	Abbott Laboratories	2017-10-24
K162020	VITROS Chemistry Products Cl- Slides	Ortho Clinical Diagnostics	2016-12-16
K082099	VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905	Ortho-Clinical Diagnostics, Inc.	2008-08-21
K070889	AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112	Wallac OY	2008-04-14
K060108	COBAS INTEGRA CHLORIDE ELCTRODE GEN.2	Roche Diagnostics Corp.	2006-02-16
K052027	OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200	Osmetech, Inc.	2005-09-29
K020148	pHoenix ISE Reagents FOR Olympus AU Chemistry Systems	Phoenix Diagnostics, Inc.	2002-02-04
K013451	PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES	Phoenix Diagnostics, Inc.	2001-12-18
K003664	DELFIA NEONATAL IRT KIT, MODEL A005-110	Wallac OY	2001-02-14
K003668	AUTODELFIA NEONATAL IRT KIT, MODEL B005-112	Wallac OY	2001-02-12
K993697	DELFIA NEONATAL IRT KIT	Wallac OY	2000-06-09
K000926	EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER	Medica Corp.	2000-05-15
K991870	ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03	A.P. Total Care, Inc.	1999-07-30
K981270	IRMA BLOOD ANALYSIS SYSTEM	Diametrics Medical, Inc.	1998-05-01

summary

Decision Summary