InSure ONE

FDA 510(k) K170548 · Enterix, Inc.

Substantially Equivalent

510(k) numberK170548

Submission

Device name
InSure ONE
Applicant
Enterix, Inc.
Edison, NJ, US
Received
February 24, 2017
Decision date
October 5, 2017
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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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
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K100031Ind One Step Fecal Occult Blood Test Model 440-10KHE · Traditional Ind Diagnostic, Inc.07/19/2010SE

More from Ind Diagnostic, Inc.

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Questions and answers

When was InSure ONE cleared by the FDA?

InSure ONE (K170548) received a 510(k) decision of Substantially Equivalent on October 5, 2017, 223 days after the submission was received.

What is the product code of K170548?

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