Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hangzhou Laihe Biotech Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co., Ltd. | 2025-03-18 | 411 | 0 |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-10 | 135 | 0 |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Dr | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 | 134 | 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