Cleared Special

INSURE II

K060930 · Enterix, Inc. · Hematology
May 2006
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K060930 is an FDA 510(k) clearance for the INSURE II, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Enterix, Inc. (Edison, US). The FDA issued a Cleared decision on May 4, 2006, 29 days after receiving the submission on April 5, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K060930 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2006
Decision Date May 04, 2006
Days to Decision 29 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement

Device Classification

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

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