Cleared Traditional

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE

K071268 · Dade Behring, Inc. · Microbiology
Jun 2007
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K071268 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE, 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 June 26, 2007, 50 days after receiving the submission on May 7, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K071268 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2007
Decision Date June 26, 2007
Days to Decision 50 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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