MACCONKEY W/SORBITOL

Culture Media, Selective And Differential

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Macconkey W/sorbitol.

Pre-market Notification Details

Device IDK872188
510k NumberK872188
Device Name:MACCONKEY W/SORBITOL
ClassificationCulture Media, Selective And Differential
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 CodeJSI  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-08
Decision Date1987-06-24

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