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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 K872252
Device Name MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT
Applicant
Labsystems, Inc.
6200 W. Oakton
Morton Grove,  IL  60053
Applicant Contact NANCY SKOWRONSKI
Correspondent
Labsystems, Inc.
6200 W. Oakton
Morton Grove,  IL  60053
Correspondent Contact NANCY SKOWRONSKI
Regulation Number866.3780
Classification Product Code
LGD  
Date Received06/11/1987
Decision Date 07/01/1987
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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