Name: Predicase
Price: 199 USD

K-number	K163538
Device name	QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
Applicant	Inova Diagnostics, Inc.
Product code	NBS
Device class	Class II
Decision date	Sep 6, 2017
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

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