10B

Culture Media, Propagating Transport

REMEL CO.

The following data is part of a premarket notification filed by Remel Co. with the FDA for 10b.

Pre-market Notification Details

Device IDK833968
510k NumberK833968
Device Name:10B
ClassificationCulture Media, Propagating Transport
Applicant REMEL CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJSN  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-16
Decision Date1983-12-30

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