MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Microscan Synergies Plus Gram-positive Mic/combo Panels With Clindamycin.

Pre-market Notification Details

Device IDK070860
510k NumberK070860
Device Name:MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant DADE BEHRING, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactRobert Eusebio
CorrespondentRobert Eusebio
DADE BEHRING, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeLON  
Subsequent Product CodeJWY
Subsequent Product CodeLRG
Subsequent Product CodeLTT
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-28
Decision Date2007-05-11
Summary:summary

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