Name: Predicase
Price: 199 USD

K-number	K220046
Device name	Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
Applicant	Shenzhen Superbio Technology Co., Ltd.
Product code	DJG
Device class	Class II
Decision date	Dec 13, 2022
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

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