Colorectal Cancer Risk Detector (TM)

FDA 510(k) K874180 · Pearce Clinical Laboratories, Inc.

Substantially Equivalent

510(k) numberK874180

Submission

Device name
Colorectal Cancer Risk Detector (TM)
Applicant
Pearce Clinical Laboratories, Inc.
Conroe, TX, US
Received
October 14, 1987
Decision date
September 30, 1988
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

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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
K864544Diabetes Risk DetectorJIL · Traditional 07/27/1987SE
K871482Hypertension Risk Detector(Tm)DXN · Traditional 06/05/1987SE

Questions and answers

When was Colorectal Cancer Risk Detector (TM) cleared by the FDA?

Colorectal Cancer Risk Detector (TM) (K874180) received a 510(k) decision of Substantially Equivalent on September 30, 1988, 352 days after the submission was received.

What is the product code of K874180?

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