510(k) K251053— Shinetell PlusTM Digital Early Pregnancy Test

Substantially Equivalent

Hangzhou AllTest Biotech Co., Ltd.

Clearance details

Applicant: Hangzhou AllTest Biotech Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2025-04-04
Decision date: 2025-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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