Cleared Traditional

H. PYLORI CHEK?

K181400 · Techlab, Inc. · Microbiology
Aug 2018
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K181400 is an FDA 510(k) clearance for the H. PYLORI CHEK?, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on August 21, 2018, 84 days after receiving the submission on May 29, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K181400 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2018
Decision Date August 21, 2018
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LYR — Helicobacter Pylori
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110

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