Cleared Special

VERSATREK

K032306 · Trek Diagnostic Systems, Inc. · Microbiology
Aug 2003
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K032306 is an FDA 510(k) clearance for the VERSATREK, a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on August 22, 2003, 28 days after receiving the submission on July 25, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K032306 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2003
Decision Date August 22, 2003
Days to Decision 28 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MDB — System, Blood Culturing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2560

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