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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic esterase--oxidase, cholesterol
510(k) Number K031824
Device Name COBAS INTEGRA CHOLESTEROL GEN. 2
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 Number862.1175
Classification Product Code
CHH  
Date Received06/13/2003
Decision Date 07/09/2003
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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