Cleared Traditional

DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM

K070346 · Dade Behring, Inc. · Microbiology
Jul 2007
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K070346 is an FDA 510(k) clearance for the DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM, a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II — Special Controls, product code LON), submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 18, 2007, 162 days after receiving the submission on February 6, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K070346 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2007
Decision Date July 18, 2007
Days to Decision 162 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1645

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