Cleared Special

Campylobacter Quik Chek

K191456 · Techlab, Inc. · Microbiology
Jun 2019
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K191456 is an FDA 510(k) clearance for the Campylobacter Quik Chek, a Campylobacter Spp. (Class I — General Controls, product code LQP), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on June 20, 2019, 20 days after receiving the submission on May 31, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K191456 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2019
Decision Date June 20, 2019
Days to Decision 20 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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