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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 K890032
Device Name IMX TOXO IGM ANTIBODY ASSAY
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact JEAN FRYDMAN
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact JEAN FRYDMAN
Regulation Number866.3780
Classification Product Code
LGD  
Date Received01/04/1989
Decision Date 06/23/1989
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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