BACTICARD STREP

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 Bacticard Strep.

Pre-market Notification Details

Device IDK936021
510k NumberK936021
Device Name:BACTICARD STREP
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactMary A Silvius
CorrespondentMary A 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 Received1993-12-17
Decision Date1994-05-20

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