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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 K914852
Device Name ELISA TOXO IGM
Applicant
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Applicant Contact MARTIN KING
Correspondent
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Correspondent Contact MARTIN KING
Regulation Number866.3780
Classification Product Code
LGD  
Date Received10/28/1991
Decision Date 01/23/1992
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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