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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K050423
Device Name OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Applicant Contact DIMITRIS DEMIRTZOGLOU
Correspondent
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Correspondent Contact DIMITRIS DEMIRTZOGLOU
Regulation Number862.1120
Classification Product Code
CHL  
Date Received02/18/2005
Decision Date 04/22/2005
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
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