THERMONUCLEASE AGAR W/TOLUIDINE BLUE

Culture Media, Non-selective And Differential

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Thermonuclease Agar W/toluidine Blue.

Pre-market Notification Details

Device IDK864205
510k NumberK864205
Device Name:THERMONUCLEASE AGAR W/TOLUIDINE BLUE
ClassificationCulture Media, Non-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 CodeJSH  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-27
Decision Date1986-11-24

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