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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 K834242
Device Name ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS
Applicant
Apple Diagnostic Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Apple Diagnostic Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3120
Classification Product Code
LJP  
Date Received12/06/1983
Decision Date 03/02/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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