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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 K864389
Device Name CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
Applicant
American Micro Scan
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact JAMES KELLER
Correspondent
American Micro Scan
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact JAMES KELLER
Regulation Number866.3120
Classification Product Code
LJP  
Date Received11/06/1986
Decision Date 12/04/1986
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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