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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 K032311
Device Name ROCHE DIAGNOSTICS OMNI S ANALYZER
Applicant
ROCHE DIAGNOSTICS CORP.
P.O. BOX 50457
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact JENNIFER TRIBBETT
Correspondent
ROCHE DIAGNOSTICS CORP.
P.O. BOX 50457
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact JENNIFER TRIBBETT
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CDS   CGA   CHL   GGF   GGZ  
GHS   GKR   JFP   JGS   KHG   KHP  
Date Received07/28/2003
Decision Date 10/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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