510(k) K233624— HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx

Substantially Equivalent

Hangzhou Aichek Medical Technology Co., Ltd.

Clearance details

Applicant: Hangzhou Aichek Medical Technology Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2023-11-13
Decision date: 2024-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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