Name: Predicase
Price: 199 USD

K-number	K061464
Device name	VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	JMO
Device class	Class I
Decision date	Jun 15, 2006
Decision	Substantially Equivalent
Regulation	862.1415

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668

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