Modified Ez Detect Occult Blood Test in Stool

FDA 510(k) K860028 · Self Care Systems, Inc.

Substantially Equivalent

510(k) numberK860028

Submission

Device name
Modified Ez Detect Occult Blood Test in Stool
Applicant
Self Care Systems, Inc.
Newport Beach, CA, US
Received
January 3, 1986
Decision date
April 7, 1986
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.,

510(k)DeviceDecision
K860923Ez Detect, 5 Minute Strep-A Color TestGTZ · Traditional 05/16/1986SE
K854358Ez Detech-Urine Blood Test SticksKHE · Traditional 04/09/1986SE

Questions and answers

When was Modified Ez Detect Occult Blood Test in Stool cleared by the FDA?

Modified Ez Detect Occult Blood Test in Stool (K860028) received a 510(k) decision of Substantially Equivalent on April 7, 1986, 94 days after the submission was received.

What is the product code of K860028?

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