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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic method, creatinine
510(k) Number K024098
Device Name COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Applicant Contact SHERRI L COENEN
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250
Correspondent Contact SHERRI L COENEN
Regulation Number862.1225
Classification Product Code
JFY  
Date Received12/12/2002
Decision Date 12/19/2002
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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