Hangzhou Laihe Biotech Co.,Ltd.
Hangzhou Zhejiang, CN
HANGZHOU LAIHE BIOTECH CO.,LTD. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Hangzhou Laihe Biotech Co.,Ltd. between 2024 and 2025. The busiest year on record is 2024, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | DJC | Substantially Equivalent | |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | LDJ | Substantially Equivalent | |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | DJG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016610313 | 3016610313 | HANGZHOU LAIHE BIOTECH CO.,LTD. | Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District, Hangzhou Zhejiang 310051 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QKPCoronavirus Antigen Detection Test System.
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- QKOReagent, Coronavirus Serological
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- DJCThin Layer Chromatography, Methamphetamine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain