MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN

Manual Antimicrobial Susceptibility Test Systems

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 With Levofloxacin.

Pre-market Notification Details

Device IDK020556
510k NumberK020556
Device Name:MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
ClassificationManual Antimicrobial Susceptibility Test Systems
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 CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-20
Decision Date2002-04-26
Summary:summary

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