ONLINE TDM TOBRAMYCIN— 510(k) K060853

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K060853 for ONLINE TDM TOBRAMYCIN, Substantially Equivalent on 2006-06-09. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code KLB
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 2006-03-29
Decision date: 2006-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.