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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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