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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Fluorescent, Chlamydia Trachomatis
510(k) Number K870946
Device Name MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
Applicant
Serono Diagnostics, Inc.
100 Longwater Circle
Norwell,  MA  02061
Applicant Contact PHILIP M FANTASIA
Correspondent
Serono Diagnostics, Inc.
100 Longwater Circle
Norwell,  MA  02061
Correspondent Contact PHILIP M FANTASIA
Regulation Number866.3120
Classification Product Code
LJP  
Date Received03/09/1987
Decision Date 04/29/1987
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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