Cleared Traditional

CAMPYLOBACTER CHEK

K173219 · Techlab, Inc. · Microbiology
Jan 2018
Decision
111d
Days
Class 1
Risk

About This 510(k) Submission

K173219 is an FDA 510(k) clearance for the CAMPYLOBACTER CHEK, a Campylobacter Spp. (Class I — General Controls, product code LQP), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on January 22, 2018, 111 days after receiving the submission on October 3, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K173219 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2017
Decision Date January 22, 2018
Days to Decision 111 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