Cleared Traditional

Curian Campy

K210976 · Meridian Bioscience, Inc. · Microbiology
Dec 2021
Decision
266d
Days
Class 1
Risk

About This 510(k) Submission

K210976 is an FDA 510(k) clearance for the Curian Campy, a Campylobacter Spp. (Class I — General Controls, product code LQP), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 23, 2021, 266 days after receiving the submission on April 1, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K210976 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2021
Decision Date December 23, 2021
Days to Decision 266 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LQP — Campylobacter Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110