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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 K955042
Device Name CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
Applicant
Shared Systems, Inc.
3961 Columbia Rd.
Martinez,  GA  30907
Applicant Contact ROBERT C HICKS
Correspondent
Shared Systems, Inc.
3961 Columbia Rd.
Martinez,  GA  30907
Correspondent Contact ROBERT C HICKS
Regulation Number866.5270
Classification Product Code
DCN  
Date Received11/03/1995
Decision Date 12/13/1995
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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