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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 K962015
Device Name RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
Applicant
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Applicant Contact K.C. CHEN, PH.D.
Correspondent
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Correspondent Contact K.C. CHEN, PH.D.
Regulation Number866.5775
Classification Product Code
DHR  
Date Received05/22/1996
Decision Date 11/25/1996
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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