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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Ha, Treponema Pallidum
510(k) Number K896410
Device Name CELLOGNOST SYPHILIS H
Applicant
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
17 Chubb Way
Somerville,  NJ  08876
Correspondent Contact JOHN E HUGHES
Regulation Number866.3830
Classification Product Code
GMT  
Date Received11/07/1989
Decision Date 05/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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