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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 K872070
Device Name CHROMOTITRE E.I.A. TOXOPLASMA IGM
Applicant
Ismunit Istituto Immunologico Intaliano
00040 Pomezia
Roma, Italia
Roma,  IT
Applicant Contact BALDUCCI, M.D.
Correspondent
Ismunit Istituto Immunologico Intaliano
00040 Pomezia
Roma, Italia
Roma,  IT
Correspondent Contact BALDUCCI, M.D.
Regulation Number866.3780
Classification Product Code
LGD  
Date Received05/29/1987
Decision Date 10/20/1987
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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