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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 the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2017-05-14 under 510(k) 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. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K162333.

When did Wondfo One Step Fecal Occult Blood (FOB) Test receive FDA 510(k) clearance?

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

Who is the listed applicant for Wondfo One Step Fecal Occult Blood (FOB) Test?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Guangzhou Wondfo Biotech Co., Ltd. as applicant

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Related Devices (Code: KHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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