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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K915320
Device Name RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
Applicant
Trinity Laboratories, Inc.
7517 Precision Dr., #107
Raleigh,  NC  27613
Applicant Contact BRUCE A CLINTON
Correspondent
Trinity Laboratories, Inc.
7517 Precision Dr., #107
Raleigh,  NC  27613
Correspondent Contact BRUCE A CLINTON
Regulation Number866.5775
Classification Product Code
DHR  
Date Received11/22/1991
Decision Date 12/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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