SELECTIVE RAPID UREA

Helicobacter Pylori

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Selective Rapid Urea.

Pre-market Notification Details

Device IDK883641
510k NumberK883641
Device Name:SELECTIVE RAPID UREA
ClassificationHelicobacter Pylori
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactBrenda Henry
CorrespondentBrenda Henry
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeLYR  
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-25
Decision Date1989-05-04

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