INDOLE SWAB

Discs, Strips And Reagents, Microorganism Differentiation

REMEL, INC.

The following data is part of a premarket notification filed by Remel, Inc. with the FDA for Indole Swab.

Pre-market Notification Details

Device IDK970833
510k NumberK970833
Device Name:INDOLE SWAB
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant REMEL, INC. 12076 SANTA FE DR. Lenexa,  KS  66215 -3594
ContactMary A Silvius
CorrespondentMary A Silvius
REMEL, INC. 12076 SANTA FE DR. Lenexa,  KS  66215 -3594
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-07
Decision Date1997-04-02

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