TOMTEC GRAM STAINER DECOLORIZER

General Purpose Reagent

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Tomtec Gram Stainer Decolorizer.

Pre-market Notification Details

Device IDK871533
510k NumberK871533
Device Name:TOMTEC GRAM STAINER DECOLORIZER
ClassificationGeneral Purpose Reagent
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactJames G Baxendale
CorrespondentJames G Baxendale
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodePPM  
CFR Regulation Number864.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-20
Decision Date1987-04-29

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