Name: Predicase
Price: 199 USD

K-number	K052645
Device name	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;
Applicant	Ortho-Clinical Diagnostics
Product code	GTQ
Device class	Class I
Decision date	Dec 14, 2005
Decision	Substantially Equivalent
Regulation	866.3720

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;

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