QXDx BCR-ABL %IS Kit For Use On The QXDx AutoDG DdPCR System

Bcr/abl1 Monitoring Test

Bio-Rad Laboratories, Inc.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Qxdx Bcr-abl %is Kit For Use On The Qxdx Autodg Ddpcr System.

Pre-market Notification Details

Device IDK181661
510k NumberK181661
Device Name:QXDx BCR-ABL %IS Kit For Use On The QXDx AutoDG DdPCR System
ClassificationBcr/abl1 Monitoring Test
Applicant Bio-Rad Laboratories, Inc. 5731 W. Las Positas Blvd Pleasanton,  CA  94588
ContactSteve Lin
CorrespondentSteve Lin
Bio-Rad Laboratories, Inc. 5731 W. Las Positas Blvd Pleasanton,  CA  94588
Product CodeOYX  
CFR Regulation Number866.6060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-25
Decision Date2019-02-13
Summary:summary

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