510(k) K071316

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN by Dade Behring, Inc. — Product Code LRG

K071316 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN". The FDA issued a decision of Substantially Equivalent on August 20, 2007. The device falls under product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems), a Class II device regulated under 21 CFR 866.1640. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.