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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Rickettsia Serological
510(k) Number K872129
Device Name LATEX R. CONORII
Applicant
Health Research, Inc.
State Of New York Dept. Of
Health Corning Tower
Albany,  NY  12201
Applicant Contact KARIM E HECHEMY
Correspondent
Health Research, Inc.
State Of New York Dept. Of
Health Corning Tower
Albany,  NY  12201
Correspondent Contact KARIM E HECHEMY
Regulation Number866.3500
Classification Product Code
LSQ  
Date Received06/02/1987
Decision Date 08/19/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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