Name: Predicase
Price: 199 USD

K-number	K240686
Device name	Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
Applicant	Healgen Scientific,, LLC
Product code	NGL
Device class	Class II
Decision date	Apr 12, 2024
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

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