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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, Cytomegalovirus
510(k) Number K891393
Device Name ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT
Applicant
Orgenics, Ltd.
1120 Vermont Ave., NW
Suite 600
Washington,  DC  20005
Applicant Contact BRUCE F MACKLER
Correspondent
Orgenics, Ltd.
1120 Vermont Ave., NW
Suite 600
Washington,  DC  20005
Correspondent Contact BRUCE F MACKLER
Regulation Number866.3175
Classification Product Code
LFZ  
Date Received03/14/1989
Decision Date 06/23/1989
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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