LOMEFLOXACIN 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 Lomefloxacin Antimicrobial Susceptibility Test Disc.

Pre-market Notification Details

Device IDK973488
510k NumberK973488
Device Name:LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant OXOID, LTD. WADE RD. Basingstoke, Hampshire,  GB Rg24 8pw
ContactAndy Holligsworth
CorrespondentAndy Holligsworth
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 Received1997-09-15
Decision Date1997-10-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384099412 K973488 000

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