Colotrak Occult Blood Test

FDA 510(k) K840527 · Breit Laboratories, Inc.

Substantially Equivalent

510(k) numberK840527

Submission

Device name
Colotrak Occult Blood Test
Applicant
Breit Laboratories, Inc.
Mchenry, IL, US
Received
February 7, 1984
Decision date
September 5, 1984
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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K162333Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional Guangzhou Wondfo Biotech Co., Ltd.05/14/2017SE
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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
K851099Igm Rheumatoid Factor Test KitDHR · Traditional 04/25/1985SE
K842137Occult Blood TestKHE · Traditional 09/05/1984SE
K832031Anti-N DNA Antibody Test KitKTL · Traditional 08/11/1983SE
K831927Antinuclear Antibody Test KitDAA · Traditional 07/18/1983SE

Questions and answers

When was Colotrak Occult Blood Test cleared by the FDA?

Colotrak Occult Blood Test (K840527) received a 510(k) decision of Substantially Equivalent on September 5, 1984, 211 days after the submission was received.

What is the product code of K840527?

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