Name: Predicase
Price: 199 USD

K-number	K221802
Device name	iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
Applicant	Mawi Dna Technologies
Product code	QBD
Device class	Class II
Decision date	Apr 3, 2023
Decision	Substantially Equivalent
Regulation	866.2950

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Source

View the full FDA submission: accessdata.fda.gov

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iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

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