Innovacon Flipcard Fecal Occult Blood Test Device

FDA 510(k) K063673 · Innovacon, Inc.

Substantially Equivalent

510(k) numberK063673

Submission

Device name
Innovacon Flipcard Fecal Occult Blood Test Device
Applicant
Innovacon, Inc.
San Diego, CA, US
Received
December 11, 2006
Decision date
March 5, 2007
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

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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
K110309Fob One Step Rapid TestKHE · Traditional Orient Gene Biotech09/14/2011SE
K102664Hema Screen ErKHE · Special Immunostics Inc.,01/28/2011SE

More from Immunostics Inc.,

510(k)DeviceDecision
K061718Innovacon Spectrum II Test CardDKZ · Special 11/13/2006SE
K062361Innovacon HCG Uktra Test DeviceJHI · Traditional 10/23/2006SE

Questions and answers

When was Innovacon Flipcard Fecal Occult Blood Test Device cleared by the FDA?

Innovacon Flipcard Fecal Occult Blood Test Device (K063673) received a 510(k) decision of Substantially Equivalent on March 5, 2007, 84 days after the submission was received.

What is the product code of K063673?

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