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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 K871196
Device Name RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
Applicant
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Applicant Contact JULIE DEMARCO
Correspondent
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Correspondent Contact JULIE DEMARCO
Regulation Number866.5775
Classification Product Code
DHR  
Date Received03/24/1987
Decision Date 05/06/1987
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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