K-number	K203489
Device name	SEFRIA PCP Oral Fluid Enzyme Immunoassay
Applicant	Immunalysis Corporation
Product code	LCM
Device class	Class U
Decision date	Apr 20, 2021
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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SEFRIA PCP Oral Fluid Enzyme Immunoassay

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