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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Campylobacter Spp.
510(k) Number K862814
Device Name COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI
Applicant
Institute Virion , Ltd.
Weingartenstrasse 9, Postfach
Ch-8803 Ruschlikon
Zurich, Switzerland,  CH
Applicant Contact EDWIN H LENNETTE,MD
Correspondent
Institute Virion , Ltd.
Weingartenstrasse 9, Postfach
Ch-8803 Ruschlikon
Zurich, Switzerland,  CH
Correspondent Contact EDWIN H LENNETTE,MD
Regulation Number866.3110
Classification Product Code
LQP  
Date Received07/24/1986
Decision Date 09/30/1986
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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