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

System, Detection, Bacterial, For Platelet Transfusion Products

Pall Corporation

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

Pre-market Notification Details

Device IDBK080014
510k NumberBK080014
Device Name:System, Detection, Bacterial, Detection Systems For Platelet Transfusion Products
ClassificationSystem, Detection, Bacterial, For Platelet Transfusion Products
Applicant Pall Corporation 25 Harbor Park Drive Port Washington,  NY  11050 US
Product CodeMZC  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-25
Decision Date2009-02-13

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