Hangzhou Laihe Biotech Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Hangzhou Laihe Biotech Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: LYHER® Oral fluid Multi-Drug Test Kit (Cube), LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette), LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
3
Total
3
Cleared
0
Denied
Hangzhou Laihe Biotech Co., Ltd. has 3 FDA 510(k) cleared medical devices. Based in Hangzhou, CN.
Latest FDA clearance: Mar 2025. Active since 2024. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Hangzhou Laihe Biotech Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Shanghai Thinkwell Consulting Co., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Hangzhou Laihe Biotech Co., Ltd.
3 devices
Cleared
Mar 18, 2025
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Toxicology
411d
Cleared
Jan 10, 2024
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC)...
Toxicology
135d
Cleared
Jan 09, 2024
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test...
Toxicology
134d