PYR/ESCULIN 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 Pyr/esculin Disk.

Pre-market Notification Details

Device IDK880950
510k NumberK880950
Device Name:PYR/ESCULIN DISK
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactBrenda Henry
CorrespondentBrenda Henry
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 Received1988-03-07
Decision Date1988-04-01

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