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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prothrombin Fragment 1.2
510(k) Number K922934
Device Name ENZYGNOST F 1+2
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 Number864.7320
Classification Product Code
MIF  
Date Received06/18/1992
Decision Date 11/16/1992
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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