Cleared Traditional

ETI-MAX 3000

K052794 · DiaSorin, Inc. · Immunology
Mar 2006
Decision
179d
Days
Class 1
Risk

About This 510(k) Submission

K052794 is an FDA 510(k) clearance for the ETI-MAX 3000, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on March 31, 2006, 179 days after receiving the submission on October 3, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number K052794 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2005
Decision Date March 31, 2006
Days to Decision 179 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2170

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