VANCOMYCIN DISK-5 MCG

Discs, Strips And Reagents, Microorganism Differentiation

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Vancomycin Disk-5 Mcg.

Pre-market Notification Details

Device IDK905151
510k NumberK905151
Device Name:VANCOMYCIN DISK-5 MCG
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactAnn Silvius
CorrespondentAnn Silvius
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-15
Decision Date1991-01-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.