Automated Cell-washing Centrifuge For Immune-hematology

Centrifuge, Cell-washing, Automated For Immuno-hematology

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Automated Cell-washing Centrifuge For Immune-hematology.

Pre-market Notification Details

Device IDBK130032
510k NumberBK130032
Device Name:Automated Cell-washing Centrifuge For Immune-hematology
ClassificationCentrifuge, Cell-washing, Automated For Immuno-hematology
Applicant Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan,  NJ  08869 US
Product CodeKSN  
CFR Regulation Number864.9285 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-01
Decision Date2013-08-09

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