Cleared Traditional

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

K071316 · Dade Behring, Inc. · Microbiology

Aug 2007

Decision

102d

Days

Class 2

Risk

About This 510(k) Submission

K071316 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN, a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II — Special Controls, product code LRG), 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 866.1640.

Submission Details

510(k) Number	K071316 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	LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640