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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 K964415
Device Name N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
Applicant
Kamiya Technology Services
P.O. Box 3238
Westport,  CT  06880
Applicant Contact MARY REES
Correspondent
Kamiya Technology Services
P.O. Box 3238
Westport,  CT  06880
Correspondent Contact MARY REES
Regulation Number866.5775
Classification Product Code
DHR  
Date Received10/01/1996
Decision Date 12/13/1996
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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