Name: Predicase
Price: 199 USD

K-number	K140971
Device name	LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.
Applicant	Randox Laboratories Limited
Product code	JJY
Device class	Class I
Decision date	Dec 8, 2014
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.

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