510(k) K150022— Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream

Substantially Equivalent

Guangzhou Wondfo Biotech Co., Ltd.

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2015-01-06
Decision date: 2015-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

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