Cleared Traditional

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN

K071317 · Dade Behring, Inc. · Microbiology
Aug 2007
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K071317 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN, 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 August 20, 2007, 102 days after receiving the submission on May 10, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K071317 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2007
Decision Date August 20, 2007
Days to Decision 102 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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