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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Fibrinogen Determination
510(k) Number K925988
Device Name MULTIFIBREN
Applicant
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Applicant Contact JOSEPH KICEINA
Correspondent
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Correspondent Contact JOSEPH KICEINA
Regulation Number864.7340
Classification Product Code
KQJ  
Date Received11/25/1992
Decision Date 03/01/1993
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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