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.
| Device ID | K181661 |
| 510k Number | K181661 |
| Device Name: | QXDx BCR-ABL %IS Kit For Use On The QXDx AutoDG DdPCR System |
| Classification | Bcr/abl1 Monitoring Test |
| Applicant | Bio-Rad Laboratories, Inc. 5731 W. Las Positas Blvd Pleasanton, CA 94588 |
| Contact | Steve Lin |
| Correspondent | Steve Lin Bio-Rad Laboratories, Inc. 5731 W. Las Positas Blvd Pleasanton, CA 94588 |
| Product Code | OYX |
| CFR Regulation Number | 866.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2019-02-13 |
| Summary: | summary |