Name: Predicase
Price: 199 USD

K-number	K152013
Device name	QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
Applicant	Inova Diagnostics, Inc.
Product code	LSW
Device class	Class II
Decision date	Apr 11, 2016
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

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