Name: Predicase
Price: 199 USD

K-number	K232864
Device name	EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
Applicant	Nantong Egens Biotechnology Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Jan 26, 2024
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

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