COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI

Campylobacter Spp.

INSTITUTE VIRION LTD.

The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Complement-fixation Test For Campylobacter Jejuni.

Pre-market Notification Details

Device IDK862814
510k NumberK862814
Device Name:COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI
ClassificationCampylobacter Spp.
Applicant INSTITUTE VIRION LTD. WEINGARTENSTRASSE 9, POSTFACH CH-8803 RUSCHLIKON Zurich, Switzerland,  CH
ContactEdwin H Lennette,md
CorrespondentEdwin H Lennette,md
INSTITUTE VIRION LTD. WEINGARTENSTRASSE 9, POSTFACH CH-8803 RUSCHLIKON Zurich, Switzerland,  CH
Product CodeLQP  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-24
Decision Date1986-09-30

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