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510(k) K052794

Device
ETI-MAX 3000
Applicant
DIASORIN, INC.
510(k) number
K052794
Product code
JJF  
Decision
Substantially Equivalent (SESE)
Decision date
2006-03-31
Date received
2005-10-03
Regulation
862.2170
Classification name
Analyzer, Chemistry, Micro, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Immunology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAROL A DEPOUW
Address
1951 Northwestern Ave. P.O. Box 285 Stillwater MN US 55082 55082

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JJF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.2004-06-16
K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.2003-12-17
K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.2002-06-05
K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.2002-02-01
K993634CARESIDE ANALYZERCareside, Inc.1999-12-02
K973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVAVital Scientific N.V.1998-03-13
K980056CARESIDE ANALYZERExigent Diagnostics, Inc.1998-03-06
K973177MAGO AUTOMATED EIA PROCESSORDiamedix Corp.1997-10-09
K971491SYNERMED IR 200 CHEMISTRY ANALYZERSynermed, Inc.1997-06-26
K964506ROCHE COBAS AMPLICOR ANALYZERRoche Molecular Systems, Inc.1997-05-21
K965103WINMAX SOFTWARE SYSTEMSDiagnostic Products Corp.1997-05-09
K964409HCL - 200 BIOCHEMISTRY ANALYZERHcl Laboratory Systems, Inc.1997-01-22
K961209BRIO AUTOMATIC SAMPLINC UNITSeac S.R.L.1996-12-24
K943978WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSISWaters Chromatography Division1995-05-02
K942676SYNCHRON CX3 DELTABeckman-Diagnostic Systems Group1994-11-02

Legacy Summary#

summary

FDA Review#

Decision Summary