PREMIER CAMPY, MODEL 618096

Campylobacter Spp.

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Premier Campy, Model 618096.

Pre-market Notification Details

Device IDK083464
510k NumberK083464
Device Name:PREMIER CAMPY, MODEL 618096
ClassificationCampylobacter Spp.
Applicant MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactSusan D Rolih
CorrespondentSusan D Rolih
MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeLQP  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-24
Decision Date2009-01-30
Summary:summary

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