TB KINYOUN CARBOLFUCHSIN

Stains, Microbiologic

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Tb Kinyoun Carbolfuchsin.

Pre-market Notification Details

Device IDK872187
510k NumberK872187
Device Name:TB KINYOUN CARBOLFUCHSIN
ClassificationStains, Microbiologic
Applicant REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
ContactJames G Baxendale
CorrespondentJames G Baxendale
REMEL CO. 12076 SANTA FE DR. Lenexa,  KS  66215
Product CodeJTS  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-08
Decision Date1987-07-29

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