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510(k) K893854

Device
Cobas Fara Ii Centrifugal Analyzer
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K893854
Product code
JJG
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-03
Date received
1989-05-25
Regulation
862.2140
Classification name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALEX WESOLOWSKI
Address
One Sunset Ave. Montclair NJ US 07042 07042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.1997-08-28
K942782PICCOLO(TM)Abaxis, Inc.1995-03-13
K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.1994-04-06
K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.1992-06-10
K910222COBAS ALPHARoche Diagnostic Systems, Inc.1991-02-27
K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, Inc.1990-10-15
K893641COBAS FARA CENTRIFUGAL ANALYZERRoche Diagnostic Systems, Inc.1989-07-20
K885203TECHNICON DAX(TM) SYSTEMTechnicon Instruments Corp.1989-03-28
K871973IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.Instrumentation Laboratory CO1987-06-11
K871838BIOMEK 1000C AUTOMATED LABORATORY WORK STATIONBeckman Instruments, Inc.1987-05-26
K854523ANALYST PHYSICIAN'S OFFICE PROFILERE.I. Dupont DE Nemours & Co., Inc.1986-01-08
K854055I.C.L.S. COMPULYZERIntegrated Computerized Laboratory Systems, Inc.1985-11-19
K851619GEN PROFILER SYSTEMElectro-Cucleonics, Inc.1985-05-14
K843914COBAS FLUORESCENCE POLARIZATION MODULERoche Diagnostic Systems, Inc.1984-11-27
K842522PDA SYSTEMAbbott Laboratories1984-08-02