MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017

Panels, Test, Susceptibility, Antimicrobial

SIEMENS HEALTHCARE DIAGNOSTICS

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Microscan Dried Gram-positive Mic/combo Panels, Model B1017.

Pre-market Notification Details

Device IDK091264
510k NumberK091264
Device Name:MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
ClassificationPanels, Test, Susceptibility, Antimicrobial
Applicant SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento,  CA  95691
ContactShannon Popson
CorrespondentShannon Popson
SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento,  CA  95691
Product CodeLTT  
Subsequent Product CodeJWY
Subsequent Product CodeLRG
Subsequent Product CodeLTW
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-30
Decision Date2009-07-22
Summary:summary

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