Cleared Traditional

POLYMEDCO OC AUTO MICRO 80 FOB TEST

K041408 · Polymedco, Inc. · Hematology

Oct 2004

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K041408 is an FDA 510(k) clearance for the POLYMEDCO OC AUTO MICRO 80 FOB TEST, a Automated Occult Blood Analyzer (Class II — Special Controls, product code OOX), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on October 21, 2004, 147 days after receiving the submission on May 27, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K041408 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2004
Decision Date	October 21, 2004
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement

Device Classification

Product Code	OOX — Automated Occult Blood Analyzer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.6550
Definition	The Automated Test System Is Intended For The Qualitative Detection Of Fecal Occult Blood In Feces By Professional Laboratories. The Automated Test Is Used For The Determination Of Gastrointestinal Bleeding.