GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS

Manual Antimicrobial Susceptibility Test Systems

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Gram Negative & Gram Positive Mic/combo Panels.

Pre-market Notification Details

Device IDK883076
510k NumberK883076
Device Name:GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant BAXTER HEALTHCARE CORP. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactWeaver Huffman
CorrespondentWeaver Huffman
BAXTER HEALTHCARE CORP. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-13
Decision Date1988-09-07

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