MEROPENEM 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 Meropenem Antimicrobial Susceptibility Test Disc.

Pre-market Notification Details

Device IDK983718
510k NumberK983718
Device Name:MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant OXOID, LTD. WADE RD. Basingstoke, Hampshire,  GB Rg24 8pw
ContactAndy Hollingsworth
CorrespondentAndy Hollingsworth
OXOID, LTD. WADE RD. Basingstoke, Hampshire,  GB Rg24 8pw
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-21
Decision Date1998-12-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384007004 K983718 000

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