REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK

Susceptibility Test Discs, Antimicrobial

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Remel Ofloxacin 5mcg Susceptibility Disk.

Pre-market Notification Details

Device IDK924766
510k NumberK924766
Device Name:REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactRobert W Feiring
CorrespondentRobert W Feiring
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-23
Decision Date1992-10-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384006694 K924766 000

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