MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 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 Tetracycline (0.006 To 16 Mcg/ml).

Pre-market Notification Details

Device IDK062923
510k NumberK062923
Device Name:MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
ClassificationInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactLibby Warriner
CorrespondentLibby Warriner
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 Received2006-09-28
Decision Date2006-10-13
Summary:summary

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