Cleared Traditional

E. HISTOLYTICA QUIK CHEK

K170728 · Techlab, Inc. · Microbiology
Jun 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K170728 is an FDA 510(k) clearance for the E. HISTOLYTICA QUIK CHEK, a Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (Class II — Special Controls, product code KHW), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on June 7, 2017, 90 days after receiving the submission on March 9, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K170728 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2017
Decision Date June 07, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code KHW — Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220

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