Cleared Traditional

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

K071076 · Dade Behring, Inc. · Microbiology
May 2007
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K071076 is an FDA 510(k) clearance for the SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS, 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 May 21, 2007, 35 days after receiving the submission on April 16, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K071076 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2007
Decision Date May 21, 2007
Days to Decision 35 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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