Name: Predicase
Price: 199 USD

K-number	K141210
Device name	QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
Applicant	Inova Diagnostics, Inc.
Product code	LLL
Device class	Class II
Decision date	Jan 29, 2015
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 SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS

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