Cleared Traditional

ENZYME IMMUNOASSAY, VANCOMYCIN

K060586 · Roche Diagnostics Corp. · Toxicology
May 2006
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K060586 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY, VANCOMYCIN, a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on May 11, 2006, 65 days after receiving the submission on March 7, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K060586 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2006
Decision Date May 11, 2006
Days to Decision 65 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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