MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 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 Erythromycin (0.015 To 2 Mcg/ml).

Pre-market Notification Details

Device IDK062375
510k NumberK062375
Device Name:MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
ClassificationInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactMaureen Mende
CorrespondentMaureen Mende
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 Received2006-08-15
Decision Date2006-10-26
Summary:summary

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