BACTIDROP(TM) SPOT INDOLE

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 Bactidrop(tm) Spot Indole.

Pre-market Notification Details

Device IDK913004
510k NumberK913004
Device Name:BACTIDROP(TM) SPOT INDOLE
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactAnn Silvius
CorrespondentAnn Silvius
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 Received1991-07-08
Decision Date1991-09-18

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