510(k) K233174— FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream

Substantially Equivalent

Assure Tech. (Hangzhou) Co, Ltd.

Clearance details

Applicant: Assure Tech. (Hangzhou) Co, Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2023-09-28
Decision date: 2024-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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