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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 K840699
Device Name CRP SLIDE TEST KIT
Applicant
DIFCO LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DIFCO LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5270
Classification Product Code
DCN  
Date Received02/16/1984
Decision Date 03/23/1984
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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