FDA 510(k), K181661, QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

510(K) Number: K181661
Device Name: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Manufacturer: Bio-Rad Laboratories, Inc.
Device Classification Name: Bcr/Abl1 Monitoring Test
Regulation Number: 866.6060
Classification Product Code: OYX
Date Received: 06/25/2018
Decision Date: 02/13/2019
Regulation Medical Specialty: Molecular Genetics

683 pages (2,190 of 2,873 original pages are fully redacted)