Cleared Special

K191442 - Campylobacter Chek (FDA 510(k) Clearance)

K191442 · Techlab, Inc. · Microbiology device
Jun 2019
Decision
21d
Days
Class 1
Risk

K191442 is an FDA 510(k) clearance for the Campylobacter Chek. This device is classified as 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, 21 days after receiving the submission on May 30, 2019.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K191442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2019
Decision Date June 20, 2019
Days to Decision 21 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