MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/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 Dried Gram-positive Mic/combo Panels With Erythromycin (0.25 - 16ug/ml).

Pre-market Notification Details

Device IDK062179
510k NumberK062179
Device Name:MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-31
Decision Date2006-08-23

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