K-number	K203564
Device name	SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
Applicant	Immunalysis Corporation
Product code	DJG
Device class	Class II
Decision date	Dec 22, 2021
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay

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