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 Gram Negative And Positive Mic/combo Panels.

Pre-market Notification Details

Device IDK893977
510k NumberK893977
Device Name:GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant BAXTER HEALTHCARE CORP. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactLorry Huffman
CorrespondentLorry 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 Received1989-06-02
Decision Date1989-08-15

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