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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Immunoperoxidase, Chlamydia Spp.
510(k) Number K910644
Device Name IPAZYME (TM) CHLAMYDIA IGG-IGA
Applicant
Savyon Diagnostics , Ltd.
Kiryat Minrav
Habosem 3,
Ashdod,  IL 77101
Applicant Contact EMMANUEL A ROSEN
Correspondent
Savyon Diagnostics , Ltd.
Kiryat Minrav
Habosem 3,
Ashdod,  IL 77101
Correspondent Contact EMMANUEL A ROSEN
Regulation Number866.3120
Classification Product Code
LKH  
Date Received02/14/1991
Decision Date 03/19/1991
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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