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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Angiotensin Converting Enzyme
510(k) Number K854876
Device Name ALDOSTERONE 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 Number862.1090
Classification Product Code
KQN  
Date Received12/06/1985
Decision Date 03/17/1986
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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