Fecal Occult Slide Test Kit

FDA 510(k) K830223 · Cambridge Chemical Products, Inc.

Substantially Equivalent

510(k) numberK830223

Submission

Device name
Fecal Occult Slide Test Kit
Applicant
Cambridge Chemical Products, Inc.
Walker, MI, US
Received
January 24, 1983
Decision date
March 7, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

More from Immunostics Inc.,

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K860793Camco Stain PakIAF · Traditional 03/18/1986SE
K781347Camco Quik Stain IIIAF · Traditional 08/21/1978SE
K770153Camco R Pak-GuaiacKHE · Traditional 02/08/1977SE

Questions and answers

When was Fecal Occult Slide Test Kit cleared by the FDA?

Fecal Occult Slide Test Kit (K830223) received a 510(k) decision of Substantially Equivalent on March 7, 1983, 42 days after the submission was received.

What is the product code of K830223?

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