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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, Rotavirus
510(k) Number K864811
Device Name ROTA-STAT
Applicant
Intl. Diagnostic Laboratories, Ltd.
91054 Jerusalem
P.O.B. :5577
Israel,  IL
Applicant Contact KASSIERER, PH.D.
Correspondent
Intl. Diagnostic Laboratories, Ltd.
91054 Jerusalem
P.O.B. :5577
Israel,  IL
Correspondent Contact KASSIERER, PH.D.
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received12/09/1986
Decision Date 08/25/1987
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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