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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Staphylococcus Aureus
510(k) Number K855220
Device Name V-TREND KIT STAPH LATEX TEST
Applicant
Texas Immunology, Inc.
P.O. Box 164
Selman City,  TX  75689
Applicant Contact CHARLES W GILL
Correspondent
Texas Immunology, Inc.
P.O. Box 164
Selman City,  TX  75689
Correspondent Contact CHARLES W GILL
Regulation Number866.2660
Classification Product Code
JWX  
Date Received12/30/1985
Decision Date 03/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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