Name: Predicase
Price: 199 USD

K-number	K043384
Device name	VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	LDO
Device class	Class II
Decision date	Feb 7, 2005
Decision	Substantially Equivalent
Regulation	862.3900

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III

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