MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN

Manual Antimicrobial Susceptibility Test Systems

SIEMENS

The following data is part of a premarket notification filed by Siemens with the FDA for Microscan Dried Gram-positive Mic/combo Panels New Antimicrobial Test - Inducible Clindamycin.

Pre-market Notification Details

Device IDK081182
510k NumberK081182
Device Name:MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant SIEMENS 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactLibby Warriner
CorrespondentLibby Warriner
SIEMENS 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeJWY  
Subsequent Product CodeLRG
Subsequent Product CodeLTT
Subsequent Product CodeLTW
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-25
Decision Date2008-08-08
Summary:summary

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