MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL

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 - Chloramphenicol.

Pre-market Notification Details

Device IDK021018
510k NumberK021018
Device Name:MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
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 Received2002-03-29
Decision Date2002-06-11
Summary:summary

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