Wondfo Propoxyphene Urine Test— 510(k) K152495

Substantially Equivalent

Guangzhou Wondfo Biotech Co., Ltd.

FDA 510(k) clearance K152495 for Wondfo Propoxyphene Urine Test, Substantially Equivalent on 2015-11-23. Applicant: Guangzhou Wondfo Biotech Co., Ltd..

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code JXN
Advisory panel: Clinical Toxicology
Date received: 2015-09-01
Decision date: 2015-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

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