MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN

Panels, Test, Susceptibility, Antimicrobial

DADE MICROSCAN, INC.

The following data is part of a premarket notification filed by Dade Microscan, Inc. with the FDA for Microscan Microstrep Plus Panel New Antimicrobial-erythromycin.

Pre-market Notification Details

Device IDK021078
510k NumberK021078
Device Name:MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
ClassificationPanels, Test, Susceptibility, Antimicrobial
Applicant DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactCynthia Van Duker
CorrespondentCynthia Van Duker
DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeLTT  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-03
Decision Date2002-06-06
Summary:summary

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