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FDA 510(k), K181661, QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
FDA 510(k), K181661, QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
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$149.00 USD
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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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