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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K864393
Device Name APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC
Applicant
Intl. Diagnostic Laboratories, Ltd.
91054 Jerusalem
P.O.B. :5577
Israel,  IL
Applicant Contact KASSIERER
Correspondent
Intl. Diagnostic Laboratories, Ltd.
91054 Jerusalem
P.O.B. :5577
Israel,  IL
Correspondent Contact KASSIERER
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received11/06/1986
Decision Date 01/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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