Wondfo One Step Fecal Occult Blood (FOB) Test— 510(k) K162333

Substantially Equivalent

Guangzhou Wondfo Biotech Co., Ltd.

FDA 510(k) clearance K162333 for Wondfo One Step Fecal Occult Blood (FOB) Test, Substantially Equivalent on 2017-05-14. Applicant: Guangzhou Wondfo Biotech Co., Ltd..

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code KHE
Advisory panel: Hematology
Date received: 2016-08-22
Decision date: 2017-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

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