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

System, Detection, Bacterial, For Platelet Transfusion Products

BioMerieux, Inc.

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

Pre-market Notification Details

Device IDBK050037
510k NumberBK050037
Device Name:System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products
ClassificationSystem, Detection, Bacterial, For Platelet Transfusion Products
Applicant bioMerieux, Inc. 100 Rodolphe Street Durham,  NC  27712 US
Product CodeMZC  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-14
Decision Date2005-12-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026126742 BK050037 000

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