DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

Manual Antimicrobial Susceptibility Test Systems

DADE MICROSCAN, INC.

The following data is part of a premarket notification filed by Dade Microscan, Inc. with the FDA for Dried Gram-negative And Gram-positive Mic/combo Panels.

Pre-market Notification Details

Device IDK983408
510k NumberK983408
Device Name:DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactSharolyn J Lentsch
CorrespondentSharolyn J Lentsch
DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-28
Decision Date1999-05-10
Summary:summary

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