Name: Predicase
Price: 199 USD

K-number	K240643
Device name	MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
Applicant	Guangzhou Decheng Biotechnology Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Jun 21, 2024
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream

Everything you need for a 510(k) submission. Nothing you don't.