Cleared Traditional

COLOSCREEN-ES

K003359 · Helena Laboratories · Hematology
Nov 2000
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K003359 is an FDA 510(k) clearance for the COLOSCREEN-ES, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 27, 2000, 31 days after receiving the submission on October 27, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K003359 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2000
Decision Date November 27, 2000
Days to Decision 31 days
Submission Type Traditional
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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