Name: Predicase
Price: 199 USD

K-number	K222558
Device name	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Applicant	Centers for Disease Control and Prevention
Product code	PBK
Device class	Class II
Decision date	Aug 30, 2022
Decision	Substantially Equivalent
Regulation	866.3315

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

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