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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 K981496
Device Name COLOR-SLIDE RF
Applicant
Seradyn, Inc.
1200 Madison Ave.
Indianapolis,  IN  46225
Applicant Contact MARTIN J WEINSTEIN
Correspondent
Seradyn, Inc.
1200 Madison Ave.
Indianapolis,  IN  46225
Correspondent Contact MARTIN J WEINSTEIN
Regulation Number866.5775
Classification Product Code
DHR  
Date Received04/27/1998
Decision Date 06/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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