MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS

Panels, Test, Susceptibility, Antimicrobial

SIEMENS HELATHCARE DIAGNOSTICS INC.

The following data is part of a premarket notification filed by Siemens Helathcare Diagnostics Inc. with the FDA for Microscan Dried Gram-postive Mic/combo Panels.

Pre-market Notification Details

Device IDK131275
510k NumberK131275
Device Name:MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
ClassificationPanels, Test, Susceptibility, Antimicrobial
Applicant SIEMENS HELATHCARE DIAGNOSTICS INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactElisabeth Wariner
CorrespondentElisabeth Wariner
SIEMENS HELATHCARE DIAGNOSTICS INC. 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 Received2013-05-03
Decision Date2013-11-08
Summary:summary

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