MYCOTRIUM-RS

Culture Media, Selective And Differential

HANA BIOLOGICS, INC.

The following data is part of a premarket notification filed by Hana Biologics, Inc. with the FDA for Mycotrium-rs.

Pre-market Notification Details

Device IDK822737
510k NumberK822737
Device Name:MYCOTRIUM-RS
ClassificationCulture Media, Selective And Differential
Applicant HANA BIOLOGICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJSI  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-09
Decision Date1982-12-03

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