Cleared Traditional

ONLINE TDM TOBRAMYCIN

K060853 · Roche Diagnostics Corp. · Toxicology
Jun 2006
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K060853 is an FDA 510(k) clearance for the ONLINE TDM TOBRAMYCIN, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on June 9, 2006, 72 days after receiving the submission on March 29, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K060853 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2006
Decision Date June 09, 2006
Days to Decision 72 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KLB — Radioimmunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

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