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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 K842797
Device Name TOXOPLASMA GONDII IGM EIA TEST KIT
Applicant
Labsystems, Inc.
P.O. Box 48723
Chicago,  IL  60648
Applicant Contact CASEY P EITNER
Correspondent
Labsystems, Inc.
P.O. Box 48723
Chicago,  IL  60648
Correspondent Contact CASEY P EITNER
Regulation Number866.3780
Classification Product Code
LGD  
Date Received07/17/1984
Decision Date 10/17/1984
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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