LYHER® Oral fluid Multi-Drug Test Kit (Cube)
K-Number: K240287 · 2025-03-18
Device Summary
Frequently Asked Questions
What is the LYHER® Oral fluid Multi-Drug Test Kit (Cube)?
LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Hangzhou Laihe Biotech Co., Ltd.. The 510(k) number is K240287.
When did LYHER® Oral fluid Multi-Drug Test Kit (Cube) receive FDA 510(k) clearance?
LYHER® Oral fluid Multi-Drug Test Kit (Cube) received FDA 510(k) clearance on 2025-03-18, under 510(k) number K240287.
Who is the listed applicant for LYHER® Oral fluid Multi-Drug Test Kit (Cube)?
The FDA 510(k) record lists Hangzhou Laihe Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LYHER® Oral fluid Multi-Drug Test Kit (Cube)?
The FDA product code for LYHER® Oral fluid Multi-Drug Test Kit (Cube) is DJC.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Hangzhou Laihe Biotech Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: DJC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.