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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Chlamydia Spp.
510(k) Number K854615
Device Name MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
Applicant
Serono Diagnostics, Inc.
11 Brooks Dr.
Bramtree,  MA  02184
Applicant Contact LAWLOR, PH.D.
Correspondent
Serono Diagnostics, Inc.
11 Brooks Dr.
Bramtree,  MA  02184
Correspondent Contact LAWLOR, PH.D.
Regulation Number866.3120
Classification Product Code
LKI  
Date Received11/18/1985
Decision Date 01/28/1986
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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