Name: Predicase
Price: 199 USD

K-number	K240351
Device name	FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
Applicant	Assure Tech., LLC
Product code	NGL
Device class	Class II
Decision date	Mar 6, 2024
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

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