Cleared Traditional

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

K160202 · Siemens Healthcare Diagnostics, Inc. · Toxicology
Apr 2016
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K160202 is an FDA 510(k) clearance for the Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL), a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on April 27, 2016, 90 days after receiving the submission on January 28, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K160202 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2016
Decision Date April 27, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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