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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 K013373
Device Name OMNI C ANALYZER
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact JENNIFER TRIBETT
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact JENNIFER TRIBETT
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   CHL   GKF   GKR   GLY  
JFP   JGS  
Date Received10/11/2001
Decision Date 11/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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