LYHER® Oral fluid Multi-Drug Test Kit (Cube)— 510(k) K240287
Substantially EquivalentHangzhou Laihe Biotech Co., Ltd.
FDA 510(k) clearance K240287 for LYHER® Oral fluid Multi-Drug Test Kit (Cube), Substantially Equivalent on 2025-03-18. Applicant: Hangzhou Laihe Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Laihe Biotech Co., Ltd.
- Product code
- Code DJC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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