Name: Predicase
Price: 199 USD

K-number	K151429
Device name	QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
Applicant	Inova Diagnostics, Inc.
Product code	LLL
Device class	Class II
Decision date	Feb 12, 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 Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

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