Name: Predicase
Price: 199 USD

K-number	K200506
Device name	DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
Applicant	Chembio Diagnostic Systems
Product code	QFO
Device class	Class II
Decision date	Jun 3, 2020
Decision	Substantially Equivalent
Regulation	866.3935

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Source

View the full FDA submission: accessdata.fda.gov

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DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader

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