DRIED GRAM-NEGATIVE MIC/COMBO PANELS

Manual Antimicrobial Susceptibility Test Systems

DADE INTL., INC.

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

Pre-market Notification Details

Device IDK970676
510k NumberK970676
Device Name:DRIED GRAM-NEGATIVE MIC/COMBO PANELS
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant DADE INTL., INC. 1584 ENTERPRISE BLVD. West Sacramento,,  CA  95691
ContactSharolyn J Lentsch
CorrespondentSharolyn J Lentsch
DADE INTL., INC. 1584 ENTERPRISE BLVD. West Sacramento,,  CA  95691
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-24
Decision Date1997-05-02
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.