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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 K813221
Device Name TOXOELISA TEST KIT
Applicant
M.A. Bioproducts
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
M.A. Bioproducts
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3780
Classification Product Code
LGD  
Date Received11/09/1981
Decision Date 01/26/1982
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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