QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System— 510(k) K181661
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K181661 for QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System, Substantially Equivalent on 2019-02-13. Applicant: Bio-Rad Laboratories, Inc..
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code OYX
- Advisory panel
- Medical Genetics
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.