INDOXYL ACETATE DISK

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 Indoxyl Acetate Disk.

Pre-market Notification Details

Device IDK923700
510k NumberK923700
Device Name:INDOXYL ACETATE DISK
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 Received1992-07-24
Decision Date1992-10-05

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