ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Susceptibility Test Discs, Antimicrobial

OXOID, LTD.

The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Ertapenem Antimicrobial Susceptibility Test Disc.

Pre-market Notification Details

Device IDK070262
510k NumberK070262
Device Name:ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant OXOID, LTD. WADE RD. Basingstoke, Hants,  GB Rg24 8pw
ContactAndy Hollingsworth
CorrespondentAndy Hollingsworth
OXOID, LTD. WADE RD. Basingstoke, Hants,  GB Rg24 8pw
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-26
Decision Date2007-03-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384133710 K070262 000

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