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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 K862196
Device Name TOXONOSTIKA IGM MICROELISA SYSTEM
Applicant
Organon Teknika Corp.
5516 Nicholson Ln.
Kensington,  TX  20895
Applicant Contact SHELDON MAZURSKY
Correspondent
Organon Teknika Corp.
5516 Nicholson Ln.
Kensington,  TX  20895
Correspondent Contact SHELDON MAZURSKY
Regulation Number866.3780
Classification Product Code
LGD  
Date Received06/09/1986
Decision Date 09/11/1986
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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