Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hangzhou AllTest Biotech Co., Ltd. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
218 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 | 87 | 0 |
| K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 | 73 | 0 |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-07-15 | 102 | 0 |
| K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 | 218 | 0 |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 | 24 | 0 |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-27 | 59 | 0 |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapi | Hangzhou AllTest Biotech Co., Ltd. | 2024-09-27 | 32 | 0 |
| K241978 | Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. | 2024-08-13 | 39 | 0 |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid | Hangzhou AllTest Biotech Co., Ltd. | 2024-06-17 | 28 | 0 |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid | Hangzhou AllTest Biotech Co., Ltd. | 2023-12-13 | 82 | 0 |
| K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023-10-26 | 16 | 0 |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023-07-31 | 49 | 0 |
| K203272 | Alltest Pregnancy Rapid Combo Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 | 451 | 0 |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Ur | Hangzhou AllTest Biotech Co., Ltd. | 2019-03-27 | 180 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda