K-number	K203272
Device name	Alltest Pregnancy Rapid Combo Test Cassette
Applicant	Hangzhou AllTest Biotech Co., Ltd.
Product code	JHI
Device class	Class II
Decision date	Jan 31, 2022
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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Alltest Pregnancy Rapid Combo Test Cassette

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