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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, Rubella
510(k) Number K872071
Device Name CHROMOTITRE E.I.A. RUBELLA IGG
Applicant
Ismunit Istituto Immunologico Intaliano
00040 Pomezia
Roma, Italia
Roma,  IT
Applicant Contact BALDUCCIM M.D.
Correspondent
Ismunit Istituto Immunologico Intaliano
00040 Pomezia
Roma, Italia
Roma,  IT
Correspondent Contact BALDUCCIM M.D.
Regulation Number866.3510
Classification Product Code
LFX  
Date Received05/29/1987
Decision Date 08/24/1987
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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