Cleared Traditional

ONLINE TDM Vancomycin Gen.3

K152245 · Roche Diagnostics Operations (Rdo) · Chemistry
Jan 2016
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K152245 is an FDA 510(k) clearance for the ONLINE TDM Vancomycin Gen.3, a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on January 8, 2016, 151 days after receiving the submission on August 10, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K152245 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2015
Decision Date January 08, 2016
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LEH — Radioimmunoassay, Vancomycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3950

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