510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240287Substantially Equivalent

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

Hangzhou Laihe Biotech Co.,Ltd., Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240287 is the FDA 510(k) clearance record for LYHER® Oral fluid Multi-Drug Test Kit (Cube), a class II device, cleared for Hangzhou Laihe Biotech Co., Ltd. on under FDA product code DJC (Thin Layer Chromatography, Methamphetamine). FDA records list 3 510(k) clearances for Hangzhou Laihe Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K240287.

Clearance record

Decision date
Received
(411 days to decision)
Product code
DJC Thin Layer Chromatography, Methamphetamine
Regulation
21 CFR 862.3610
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Hangzhou Laihe Biotech Co., Ltd. Rm. 401-406, F1-3, Bldg. 1, #425 Miaohouwang Rd., Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJC

Trailing 12 months
1 clearance under product code DJC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DJC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260