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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nadh oxidation/nad reduction, ast/sgot
510(k) Number K071211
Device Name COBAS C 111 ANALYZER
Applicant
Roche Diagnostics
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact CORINA HARPER
Correspondent
Roche Diagnostics
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact CORINA HARPER
Regulation Number862.1100
Classification Product Code
CIT  
Subsequent Product Codes
CEM   CFR   CGZ   DCN   JGS  
JJE  
Date Received05/01/2007
Decision Date 07/30/2007
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
Recalls CDRH Recalls
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