DRIED GRAM-POSITIVE MIC/COMBO PANELS

Manual Antimicrobial Susceptibility Test Systems

BAXTER DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK944651
510k NumberK944651
Device Name:DRIED GRAM-POSITIVE MIC/COMBO PANELS
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant BAXTER DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactSharon K Cullen
CorrespondentSharon K Cullen
BAXTER DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-26
Decision Date1994-11-18

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