MICROSTREP PLUS PANEL, AZITHROMYCIN

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 Microstrep Plus Panel, Azithromycin.

Pre-market Notification Details

Device IDK021169
510k NumberK021169
Device Name:MICROSTREP PLUS PANEL, AZITHROMYCIN
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 Received2002-04-11
Decision Date2002-06-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.