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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.
Indianapolos,  IN  46250
Applicant Contact SHERRI L COENEN
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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