OFPBL

Culture Media, Selective And Differential

REMEL CO.

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

Pre-market Notification Details

Device IDK860707
510k NumberK860707
Device Name:OFPBL
ClassificationCulture Media, Selective And Differential
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 CodeJSI  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-26
Decision Date1986-03-11

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