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FDA 510(k)

Wondfo One Step Fecal Occult Blood (FOB) Test

K-Number: K162333 · 2017-05-14

ApplicantGuangzhou Wondfo Biotech Co., Ltd.
Decision Date2017-05-14
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Wondfo One Step Fecal Occult Blood (FOB) Test is a medical device manufactured by Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2017-05-14 under approval number K162333. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wondfo One Step Fecal Occult Blood (FOB) Test?

Wondfo One Step Fecal Occult Blood (FOB) Test is a medical device that received FDA 510(k) clearance on 2017-05-14. It is manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K162333.

When was Wondfo One Step Fecal Occult Blood (FOB) Test approved by the FDA?

Wondfo One Step Fecal Occult Blood (FOB) Test received FDA 510(k) clearance on 2017-05-14, under approval number K162333.

What company makes Wondfo One Step Fecal Occult Blood (FOB) Test?

Wondfo One Step Fecal Occult Blood (FOB) Test is manufactured by Guangzhou Wondfo Biotech Co., Ltd..

What is the FDA product code for Wondfo One Step Fecal Occult Blood (FOB) Test?

The FDA product code for Wondfo One Step Fecal Occult Blood (FOB) Test is KHE.

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Related Devices (Code: KHE)

K170548InSure ONEEnterix, Inc. K171484hema-screen SPECIFIC GoldImmunostics Inc., K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc., K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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