FDA 510(k) Premarket Notification K162333: Wondfo One Step Fecal Occult Blood (FOB) Test

Submission Details & Decision

Normalized public record details for 510(k) notification K162333.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K162333

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

Wondfo One Step Fecal Occult Blood (FOB) Test

Product Code

KHE

Decision Date

2017-05-14

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

2016-08-22

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