510(k) K193132— CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream

Substantially Equivalent

Hangzhou Clongene Biotech Co., Ltd.

Clearance details

Applicant: Hangzhou Clongene Biotech Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2019-11-12
Decision date: 2019-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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