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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 K851389
Device Name APO B RIA KIT
Applicant
Iso-Tex Diagnostics
P.O. Box 909
Friendswood,  TX  77549
Applicant Contact EDWARD G EZRAILSON
Correspondent
Iso-Tex Diagnostics
P.O. Box 909
Friendswood,  TX  77549
Correspondent Contact EDWARD G EZRAILSON
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received04/09/1985
Decision Date 07/10/1985
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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