Cleared Traditional

Sofia 2 Campylobacter FIA

K211342 · Quidel Corporation · Microbiology
Nov 2021
Decision
204d
Days
Class 1
Risk

About This 510(k) Submission

K211342 is an FDA 510(k) clearance for the Sofia 2 Campylobacter FIA, a Campylobacter Spp. (Class I — General Controls, product code LQP), submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on November 23, 2021, 204 days after receiving the submission on May 3, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K211342 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2021
Decision Date November 23, 2021
Days to Decision 204 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