Etest Ceftaroline (0.002 - 32ug/ml)

Manual Antimicrobial Susceptibility Test Systems

BIOMERIEUX SA

The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Ceftaroline (0.002 - 32ug/ml).

Pre-market Notification Details

Device IDK151873
510k NumberK151873
Device Name:Etest Ceftaroline (0.002 - 32ug/ml)
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant BIOMERIEUX SA 5, RUE DES AQUEDUCS Craponne,  FR 69290
ContactClaire Dumas
CorrespondentClaire Dumas
BIOMERIEUX SA 5, RUE DES AQUEDUCS Craponne,  FR 69290
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-09
Decision Date2015-10-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026261658 K151873 000
03573026624415 K151873 000

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