TODD HEWITT W/CNA (LIM BROTH)

Culture Media, Selective Broth

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for Todd Hewitt W/cna (lim Broth).

Pre-market Notification Details

Device IDK871447
510k NumberK871447
Device Name:TODD HEWITT W/CNA (LIM BROTH)
ClassificationCulture Media, Selective Broth
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 CodeJSD  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-13
Decision Date1987-05-13

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