FDA 510(k) Applications Submitted by Hangzhou AllTest Biotech Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K251053 04/04/2025 Shinetell PlusTM Digital Early Pregnancy Test Hangzhou AllTest Biotech Co., Ltd.
K231698 06/12/2023 AllTest Fentanyl Rapid Test (Urine) Hangzhou AllTest Biotech Co., Ltd.
K241978 07/05/2024 Shinetell Digital Pregnancy Test Hangzhou AllTest Biotech Co., Ltd.


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