510(k) K183097— Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream

Substantially Equivalent

Weihai Kangzhou Biotechnology Engineering Co., Ltd.

Clearance details

Applicant: Weihai Kangzhou Biotechnology Engineering Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2018-11-07
Decision date: 2019-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weihai City, CN

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.