Cleared Traditional

Instant-view-PLUS immunochemical Fecal Occult Blood Test

K173212 · Alfa Scientific Designs, Inc. · Hematology
Feb 2018
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K173212 is an FDA 510(k) clearance for the Instant-view-PLUS immunochemical Fecal Occult Blood Test, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on February 15, 2018, 136 days after receiving the submission on October 2, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K173212 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2017
Decision Date February 15, 2018
Days to Decision 136 days
Submission Type Traditional
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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