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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, Toxoplasma Gondii
510(k) Number K885344
Device Name IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT
Applicant
Orgenics, Ltd.
1120 Vermont Ave., NW
Suite 600
Washington,  DC  20005
Applicant Contact MACKLER, PHD
Correspondent
Orgenics, Ltd.
1120 Vermont Ave., NW
Suite 600
Washington,  DC  20005
Correspondent Contact MACKLER, PHD
Regulation Number866.3780
Classification Product Code
LGD  
Date Received12/28/1988
Decision Date 04/12/1989
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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