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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K874638
Device Name V-TREND BETA-HCG TEST
Applicant
TEXAS IMMUNOLOGY, INC.
5400 SPUR 248
TYLER,  TX  75707
Applicant Contact CHARLES W GILL
Correspondent
TEXAS IMMUNOLOGY, INC.
5400 SPUR 248
TYLER,  TX  75707
Correspondent Contact CHARLES W GILL
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received11/12/1987
Decision Date 01/21/1988
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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