ETEST CEFTAROLINE

Manual Antimicrobial Susceptibility Test Systems

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Etest Ceftaroline.

Pre-market Notification Details

Device IDK121002
510k NumberK121002
Device Name:ETEST CEFTAROLINE
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
ContactJennifer Chia-hsuan Lin
CorrespondentJennifer Chia-hsuan Lin
BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood,  MO  63042
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-02
Decision Date2012-10-12
Summary:summary

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