Cleared Traditional

IMMULITE 2000, IMMULITE 2500 VANCOMYCIN

K063045 · Diagnostic Products Corp. · Toxicology
Dec 2006
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K063045 is an FDA 510(k) clearance for the IMMULITE 2000, IMMULITE 2500 VANCOMYCIN, a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 5, 2006, 62 days after receiving the submission on October 4, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K063045 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2006
Decision Date December 05, 2006
Days to Decision 62 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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