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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 K854819
Device Name CPR SLIDE EIKEN
Applicant
Syn-Kit, Inc.
9231 Eton Ave.
Chatsworth,  CA  91311
Applicant Contact JAMES F GODFREY
Correspondent
Syn-Kit, Inc.
9231 Eton Ave.
Chatsworth,  CA  91311
Correspondent Contact JAMES F GODFREY
Regulation Number866.5270
Classification Product Code
DCN  
Date Received12/03/1985
Decision Date 02/26/1986
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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