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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cortisol
510(k) Number K895407
Device Name CORTISOL CLASP-BEAD EIA 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 Number862.1205
Classification Product Code
CGR  
Date Received09/06/1989
Decision Date 10/19/1989
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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