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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 K790012
Device Name RHEUMOGEN TEST SYSTEM
Applicant
Calbiochem-Behring Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Calbiochem-Behring Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5775
Classification Product Code
DHR  
Date Received01/02/1979
Decision Date 01/26/1979
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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