Cleared Special

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

K163554 · Immunostics Inc., · Hematology
Jan 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K163554 is an FDA 510(k) clearance for the hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on January 17, 2017, 29 days after receiving the submission on December 19, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K163554 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2016
Decision Date January 17, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KHE — Reagent, Occult Blood
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6550

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