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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K885292
Device Name COBAS MFC
Applicant
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Applicant Contact ALEX WESOLOWSKI
Correspondent
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Correspondent Contact ALEX WESOLOWSKI
Regulation Number862.2100
Classification Product Code
JQP  
Date Received12/27/1988
Decision Date 03/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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