DRIED GRAM-NEGATIVE AND 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 Dried Gram-negative And Positive Mic/combo Panels.

Pre-market Notification Details

Device IDK922458
510k NumberK922458
Device Name:DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant BAXTER HEALTHCARE CORP. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactKarla Tomfohrde
CorrespondentKarla Tomfohrde
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 Received1992-05-26
Decision Date1992-12-11

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