Cleared Traditional

!NSURE FECAL OCCULT BLOOD TEST

K002457 · Enterix, Inc. · Hematology

Jan 2001

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K002457 is an FDA 510(k) clearance for the !NSURE FECAL OCCULT BLOOD TEST, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Enterix, Inc. (Falmouth,, US). The FDA issued a Cleared decision on January 12, 2001, 155 days after receiving the submission on August 10, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K002457 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 2000
Decision Date	January 12, 2001
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF