Name: Predicase
Price: 199 USD

K-number	K140522
Device name	RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
Applicant	Randox Laboratories Limited
Product code	JJY
Device class	Class I
Decision date	May 22, 2014
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL

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