Cleared Traditional

I-CHROMA IFOB WITH I-CHROMA READER

K132167 · Boditech Med, Inc. · Hematology
May 2014
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K132167 is an FDA 510(k) clearance for the I-CHROMA IFOB WITH I-CHROMA READER, a Automated Occult Blood Analyzer (Class II — Special Controls, product code OOX), submitted by Boditech Med, Inc. (Chuncheon-Si, Gang-Won-Do, KR). The FDA issued a Cleared decision on May 2, 2014, 294 days after receiving the submission on July 12, 2013. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K132167 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2013
Decision Date May 02, 2014
Days to Decision 294 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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.