Name: Predicase
Price: 199 USD

K-number	K213808
Device name	Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
Applicant	Co-Innovation Biotech Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Apr 5, 2022
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream

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