# Hangzhou Laihe Biotech Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 3 (2024–2025): 3 510(k) clearances
- Product codes: DJC (1), LDJ (1), DJG (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advin Biotech, Inc.: 2 (https://510kreport.com/company/advin-biotech)
- Premier Biotech, Inc.: 1 (https://510kreport.com/company/premier-biotech)

## Recent decisions
- K240287: LYHER® Oral fluid Multi-Drug Test Kit (Cube) (Mar 18, 2025)
- K232604: LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) (Jan 10, 2024)
- K232597: LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi-Drug Test Kit (Cassette), LYHER® Urine Multi-Drug Test Kit (Dipcard) (Jan 9, 2024)

Source page: https://510kreport.com/company/hangzhou-laihe-biotech