Name: Predicase
Price: 199 USD

K-number	K233062
Device name	BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
Applicant	Vivachek Biotech (Hangzhou) Co., Ltd.
Product code	NFT
Device class	Class II
Decision date	Nov 2, 2023
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx

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