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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 K111188
Device Name COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact Sarah Baumann
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Sarah Baumann
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   GGZ   GHS   GKA  
GKF   GLY   JFP   JGS   JJY   KHG  
KHP  
Date Received04/27/2011
Decision Date 05/14/2012
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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