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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 K802448
Device Name RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
Applicant
Syn-Kit, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Syn-Kit, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5775
Classification Product Code
DHR  
Date Received10/08/1980
Decision Date 01/05/1981
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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