SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE

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 Synergies Plus Gram-positive Mic/combo Panels With Gentamicin (0.06-32mg/ml Long Dilution Sequence.

Pre-market Notification Details

Device IDK063365
510k NumberK063365
Device Name:SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactRobert Eusebio
CorrespondentRobert Eusebio
DADE BEHRING, INC. 2040 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 Received2006-11-07
Decision Date2006-12-08
Summary:summary

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