Fob One Step Rapid Test

FDA 510(k) K110309 · Orient Gene Biotech

Substantially Equivalent

510(k) numberK110309

Submission

Device name
Fob One Step Rapid Test
Applicant
Orient Gene Biotech
East Stroudsburg, PA, US
Received
February 2, 2011
Decision date
September 14, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KHE – Reagent, Occult Blood
Device class
Class II (moderate risk)
Regulation
21 CFR 864.6550
Specialty
Hematology

Other 510(k)s with product code KHE

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K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional Alfa Scientific Designs, Inc.02/15/2018SE
K170548InSure ONEKHE · Traditional Enterix, Inc.10/05/2017SE
K171484hema-screen SPECIFIC GoldKHE · Special Immunostics Inc.,06/14/2017SE
K162333Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional Guangzhou Wondfo Biotech Co., Ltd.05/14/2017SE
K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special Immunostics Inc.,01/17/2017SE
K143325OC-Light S FITKHE · Traditional Eiken Chemical Co., Ltd.08/20/2015SE
K121397Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitKHE · Traditional SEKISUI Diagnostics, LLC12/28/2012SE
K113506Ind One Step Occult Blood (Fob) TestKHE · Special Ind Diagnostics, Inc.12/19/2012SE
K102664Hema Screen ErKHE · Special Immunostics Inc.,01/28/2011SE
K100031Ind One Step Fecal Occult Blood Test Model 440-10KHE · Traditional Ind Diagnostic, Inc.07/19/2010SE

Questions and answers

When was Fob One Step Rapid Test cleared by the FDA?

Fob One Step Rapid Test (K110309) received a 510(k) decision of Substantially Equivalent on September 14, 2011, 224 days after the submission was received.

What is the product code of K110309?

The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.