MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Microscan Microstrep Plus Panel Cefepime (o.015 - 8 Mcg/ml).

Pre-market Notification Details

Device IDK063099
510k NumberK063099
Device Name:MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
ClassificationInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactMay Morishima
CorrespondentMay Morishima
DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeLRG  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-10
Decision Date2006-11-01
Summary:summary

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