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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 K942328
Device Name N LATEX RF
Applicant
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number866.5775
Classification Product Code
DHR  
Date Received05/05/1994
Decision Date 10/20/1994
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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