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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
510(k) Number K895468
Device Name ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
Applicant
Orgenics, Ltd.
P.O. Box 2443
Columbia,  MD  21043
Applicant Contact CONSTANCE DUCAR
Correspondent
Orgenics, Ltd.
P.O. Box 2443
Columbia,  MD  21043
Correspondent Contact CONSTANCE DUCAR
Regulation Number866.3120
Classification Product Code
LJC  
Date Received09/11/1989
Decision Date 03/13/1990
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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