Name: Predicase
Price: 199 USD

K-number	K041687
Device name	ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
Applicant	Abbott Laboratories
Product code	JJX
Device class	Class I
Decision date	Aug 18, 2004
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR

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