REMEL CEFPODOXIME 10 MCG 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 Cefpodoxime 10 Mcg Susceptibility Disk.

Pre-market Notification Details

Device IDK931289
510k NumberK931289
Device Name:REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactRobert Feiring
CorrespondentRobert 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 Received1993-03-12
Decision Date1993-06-02

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