Cleared Traditional

AFIAS iFOB with AFIAS-50

K163225 · Immunostics Inc., · Hematology

Aug 2017

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K163225 is an FDA 510(k) clearance for the AFIAS iFOB with AFIAS-50, a Automated Occult Blood Analyzer (Class II — Special Controls, product code OOX), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on August 8, 2017, 264 days after receiving the submission on November 17, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number	K163225 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2016
Decision Date	August 08, 2017
Days to Decision	264 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.