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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, C-Reactive Protein
510(k) Number K860679
Device Name IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
Applicant
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Applicant Contact TIMO RAINES
Correspondent
Orion Corp.
P.O. Box 425
20101 Turku,  FI
Correspondent Contact TIMO RAINES
Regulation Number866.5270
Classification Product Code
DCN  
Date Received02/25/1986
Decision Date 08/04/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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