Name: Predicase
Price: 199 USD

K-number	K232597
Device name	LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
Applicant	Hangzhou Laihe Biotech Co., Ltd.
Product code	DJG
Device class	Class II
Decision date	Jan 9, 2024
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

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