FDA 510(k) Applications Submitted by Rosa Wu
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250727 |
03/11/2025 |
AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup |
Hangzhou Alltest Biotech Co.,Ltd |
| K251053 |
04/04/2025 |
Shinetell PlusTM Digital Early Pregnancy Test |
Hangzhou AllTest Biotech Co., Ltd. |
| K241428 |
05/20/2024 |
AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup |
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. |
| K242540 |
08/26/2024 |
AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel |
Hangzhou Alltest Biotech Co.,Ltd |
| K242576 |
08/29/2024 |
AllTest Viral Transport Medium |
Hangzhou Alltest Biotech Co.,Ltd |
| K233019 |
09/22/2023 |
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx |
Hangzhou AllTest Biotech Co.,Ltd |
| K233417 |
10/10/2023 |
AllTest Fentanyl Urine Test Cassette |
Hangzhou AllTest Biotech Co.,Ltd |
| K203272 |
11/06/2020 |
Alltest Pregnancy Rapid Combo Test Cassette |
Hangzhou AllTest Biotech Co., Ltd |
| K244043 |
12/30/2024 |
AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup |
Hangzhou Alltest Biotech Co.,Ltd |
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