Guangzhou Decheng Biotechnology Co., Ltd.

Code	Device name	Class	Specialty	Clearances	Most recent
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Class II	Clinical Chemistry	4	2025-09-09
NGL	Test, Opiates, Over The Counter	Class II	Clinical Toxicology	2	2025-02-20
DJG	Enzyme Immunoassay, Opiates	Class II	Clinical Toxicology	2	2024-05-10

Date	K-number	Device	Code	Class	Specialty
2025-09-09	K251040	MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test	LCX	Class II	Clinical Chemistry
2025-02-20	K250067	Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro	NGL	Class II	Clinical Toxicology
2025-02-06	K242428	Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus	NGL	Class II	Clinical Toxicology
2024-06-21	K240643	MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream	LCX	Class II	Clinical Chemistry
2024-05-10	K240698	Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard	DJG	Class II	Clinical Toxicology
2023-12-13	K232659	Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup	DJG	Class II	Clinical Toxicology
2023-02-28	K230038	MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)	LCX	Class II	Clinical Chemistry
2022-11-30	K222305	MissLan Digital Pregnancy Rapid Test	LCX	Class II	Clinical Chemistry

Clearance cadence by quarter