Cleared Traditional

CEDIA VANCOMYCIN ASSAY

K032811 · Microgenics Corp. · Toxicology
Nov 2003
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K032811 is an FDA 510(k) clearance for the CEDIA VANCOMYCIN ASSAY, a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on November 24, 2003, 76 days after receiving the submission on September 9, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K032811 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2003
Decision Date November 24, 2003
Days to Decision 76 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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