MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME

Manual Antimicrobial Susceptibility Test Systems

DADE BEHRING, INC.

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

Pre-market Notification Details

Device IDK020820
510k NumberK020820
Device Name:MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactCynthia Van Duker
CorrespondentCynthia Van Duker
DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-13
Decision Date2002-05-09
Summary:summary

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