510(k) K043384

Device: VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III
Applicant: Ortho-Clinical Diagnostics, Inc.
510(k) number: K043384
Product code: LDO
Decision: Substantially Equivalent (SESE)
Decision date: 2005-02-07
Date received: 2004-12-09
Regulation: 862.3900
Classification name: Enzymatic Radiochemical Assay, Tobramycin
Medical specialty: Toxicology
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K841556	HEART - AID ALS, 95	Cardiac Resucitator Corp.	1984-07-19
K832055	EMIT ASSAY AND TOBRAMYCIN	Syva Co.	1983-08-08

summary

Decision Summary