MissLan® Early Detection Pregnancy Test Strip +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240643

by Guangzhou Decheng Biotechnology Co., Ltd.

Identifiers

510(k) Number: K240643 FDA 510(k)
FDA Product Code: LCX FDA 510(k)
Models / Variants: MissLan® Early Detection Pregnancy Test Strip FDA 510(k)
MissLan® Early Detection Pregnancy Test Cassette FDA 510(k)
MissLan® Early Detection Pregnancy Test Midstream FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.1155 FDA 510(k)
Regulation Number: 862.1155 FDA 510(k)
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

MissLan® Early Detection Pregnancy Test Strip +2 more models by Guangzhou Decheng Biotechnology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K240643	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.

Sources (1)

FDA 510(k) K240643 24 fields · synced Jun 18, 2026