Kit, Bone Marrow Collection

Bone Marrow Collection/transfusion Kit

Fresenius Kabi

The following data is part of a premarket notification filed by Fresenius Kabi with the FDA for Kit, Bone Marrow Collection.

Pre-market Notification Details

Device IDBK170030
510k NumberBK170030
Device Name:Kit, Bone Marrow Collection
ClassificationBone Marrow Collection/transfusion Kit
Applicant Fresenius Kabi three Corporate Drive Lake Zurich,  IL  60047
Product CodeLWE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-30
Decision Date2017-07-24

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