K-number	K232898
Device name	Quantisal Oral Fluid Collection Device
Applicant	Immunalysis Corporation
Product code	PJD
Device class	Class II
Decision date	Nov 21, 2023
Decision	Substantially Equivalent
Regulation	862.1675

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Source

View the full FDA submission: accessdata.fda.gov

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Quantisal Oral Fluid Collection Device

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Quantisal Oral Fluid Collection Device