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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf, Typhus Fever Group
510(k) Number K924395
Device Name NEOTHROMITIN(R)
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 Number866.3500
Classification Product Code
GPO  
Date Received08/31/1992
Decision Date 12/01/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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