The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Bcr-abl Ultra, Genexpert Dx System, Genexpert Infinity-48s And Genexpert Infinity-80 Systems.
| Device ID | K190076 |
| 510k Number | K190076 |
| Device Name: | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems |
| Classification | Bcr/abl1 Monitoring Test |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Yi-ping Lin |
| Correspondent | Sudhakar Marla Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | OYX |
| CFR Regulation Number | 866.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-16 |
| Decision Date | 2019-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940007102 | K190076 | 000 |