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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K851540
Device Name ESTRADIOL DIRECT RIA KIT
Applicant
Biotecx Laboratories, Inc.
P.O. Box 1421
Friendswood,  TX  77546
Applicant Contact MOHAN MEHRA
Correspondent
Biotecx Laboratories, Inc.
P.O. Box 1421
Friendswood,  TX  77546
Correspondent Contact MOHAN MEHRA
Regulation Number862.1260
Classification Product Code
CHP  
Date Received04/16/1985
Decision Date 06/06/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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