REMEL CEFEPIME 30 UG 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 Cefepime 30 Ug Susceptibility Disk.

Pre-market Notification Details

Device IDK955669
510k NumberK955669
Device Name:REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactMary Ann Silvius
CorrespondentMary Ann Silvius
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 Received1995-12-13
Decision Date1996-02-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384006991 K955669 000

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