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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 K872539
Device Name EUROGENETICS CRP ELISA
Applicant
Eurogenetics
583 Mountain Ave.
North Caldwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Eurogenetics
583 Mountain Ave.
North Caldwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number866.5270
Classification Product Code
DCN  
Date Received06/29/1987
Decision Date 10/20/1987
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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