Hangzhou AllTest Biotech Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252607 | AllTest Urinary Tract Infection Test | October 30, 2025 |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | July 15, 2025 |
| K242576 | AllTest Viral Transport Medium | April 4, 2025 |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | April 4, 2025 |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | February 27, 2025 |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | September 27, 2024 |
| K241978 | Shinetell Digital Pregnancy Test | August 13, 2024 |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | June 17, 2024 |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Tes | December 13, 2023 |
| K233417 | AllTest Fentanyl Urine Test Cassette | October 26, 2023 |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | July 31, 2023 |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | January 31, 2022 |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test P | March 27, 2019 |