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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K842717
Device Name COBAS-FIBRO
Applicant
Roche Diagnostic Systems, Inc.
Nutley,  NJ  07110
Applicant Contact GRIFFIN FITZGERALD
Correspondent
Roche Diagnostic Systems, Inc.
Nutley,  NJ  07110
Correspondent Contact GRIFFIN FITZGERALD
Regulation Number864.5425
Classification Product Code
JPA  
Date Received07/13/1984
Decision Date 10/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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