Cleared Traditional

DBEST OCCULT BLOOD TEST KIT

K984269 · Ameritek, Inc. · Hematology
May 1999
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K984269 is an FDA 510(k) clearance for the DBEST OCCULT BLOOD TEST KIT, a Reagent, Occult Blood (Class II — Special Controls, product code KHE), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on May 11, 1999, 201 days after receiving the submission on October 22, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.

Submission Details

510(k) Number K984269 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1998
Decision Date May 11, 1999
Days to Decision 201 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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

Similar Devices — KHE Reagent, Occult Blood

All 96
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · Alfa Scientific Designs, Inc. · Feb 2018
InSure ONE
K170548 · Enterix, Inc. · Oct 2017
hema-screen SPECIFIC Gold
K171484 · Immunostics Inc., · Jun 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · Guangzhou Wondfo Biotech Co., Ltd. · May 2017
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
K163554 · Immunostics Inc., · Jan 2017
OC-Light S FIT
K143325 · Eiken Chemical Co., Ltd. · Aug 2015