Cleared Traditional

InSure ONE

K170548 · Enterix, Inc. · Hematology
Oct 2017
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K170548 is an FDA 510(k) clearance for the InSure ONE, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Enterix, Inc. (Edison, US). The FDA issued a Cleared decision on October 5, 2017, 223 days after receiving the submission on February 24, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K170548 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2017
Decision Date October 05, 2017
Days to Decision 223 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KHE — Reagent, Occult Blood
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6550

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