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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estriol
510(k) Number K844767
Device Name RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
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 Number862.1265
Classification Product Code
CGI  
Date Received12/07/1984
Decision Date 02/01/1985
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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