Curian Campy

Campylobacter Spp.

Meridian Bioscience, Inc.

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

Pre-market Notification Details

Device IDK210976
510k NumberK210976
Device Name:Curian Campy
ClassificationCampylobacter Spp.
Applicant Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati,  OH  45244
ContactHeather Planck
CorrespondentHeather Planck
Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati,  OH  45244
Product CodeLQP  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-01
Decision Date2021-12-23

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