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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K060373
Device Name COBAS 6000 SERIES SYSTEM
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Applicant Contact KERWIN KAUFMAN
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Correspondent Contact KERWIN KAUFMAN
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   CZW   DJG   JFJ   JGS  
JJE   KNK   LDP  
Date Received02/13/2006
Decision Date 03/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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