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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, rheumatoid factor
510(k) Number K953261
Device Name CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
Original Applicant
SHARED SYSTEMS, INC.
3961 columbia rd.
martinez,  GA  30907
Original Contact robert c hicks
Regulation Number866.5775
Classification Product Code
DHR  
Date Received07/12/1995
Decision Date 08/15/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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