System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products

System, Detection, Bacterial, For Platelet Transfusion Products

Becton, Dickinson & Company

The following data is part of a premarket notification filed by Becton, Dickinson & Company with the FDA for System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products.

Pre-market Notification Details

Device IDBK200530
510k NumberBK200530
Device Name:System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products
ClassificationSystem, Detection, Bacterial, For Platelet Transfusion Products
Applicant Becton, Dickinson & Company 7 Loveton Circle, Mc 694 Sparks,  MD  21152 0999
Product CodeMZC  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-14
Decision Date2020-12-23

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