Name: Predicase
Price: 199 USD

K-number	DEN220039
Device name	Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
Applicant	Quidel Corporation
Product code	QVF
Device class	Class II
Decision date	Mar 8, 2023
Decision	Not Substantially Equivalent
Regulation	866.3982

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Source

View the full FDA submission: accessdata.fda.gov

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Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

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