Name: Predicase
Price: 199 USD

K-number	K200133
Device name	hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
Applicant	Safecare Biotech (Hangzhou) Co., Ltd.
Product code	LCX
Device class	Class II
Decision date	Aug 13, 2020
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream

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