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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, (Chlamydiae Group)
510(k) Number K914327
Device Name SEROELISA(TM) CHLAMYDIA IGA TEST KIT
Applicant
Savyon Diagnostics , Ltd.
Kiryat Minrav
Habosem 3,
Ashdod,  IL 77101
Applicant Contact YAKIR
Correspondent
Savyon Diagnostics , Ltd.
Kiryat Minrav
Habosem 3,
Ashdod,  IL 77101
Correspondent Contact YAKIR
Regulation Number866.3120
Classification Product Code
LJC  
Date Received09/27/1991
Decision Date 06/09/1992
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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