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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 K933712
Device Name EL-RF TEST SYSTEM: EL-RF-IGM KIT
Applicant
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612
Applicant Contact CHRISTOPHER J FROELICH
Correspondent
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612
Correspondent Contact CHRISTOPHER J FROELICH
Regulation Number866.5775
Classification Product Code
DHR  
Date Received07/30/1993
Decision Date 01/28/1994
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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