K-number	K181135
Device name	Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
Applicant	Immunalysis Corporation
Product code	LCM
Device class	Class U
Decision date	Jan 24, 2019
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay

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