MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 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 Cefaclor (0.5 - 8 Mcg/ml).

Pre-market Notification Details

Device IDK063102
510k NumberK063102
Device Name:MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
ClassificationInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactShannon Popson
CorrespondentShannon Popson
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 Date2006-11-09
Summary:summary

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