Name: Predicase
Price: 199 USD

K-number	K232604
Device name	LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
Applicant	Hangzhou Laihe Biotech Co., Ltd.
Product code	LDJ
Device class	Class II
Decision date	Jan 10, 2024
Decision	Substantially Equivalent
Regulation	862.3870

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Source

View the full FDA submission: accessdata.fda.gov

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LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)

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