The following data is part of a premarket notification filed by Accelerate Diagnostics, Inc. with the FDA for Accelerate Pheno System, Accelerate Phenotest Bc Kit.
| Device ID | K192665 |
| 510k Number | K192665 |
| Device Name: | Accelerate Pheno System, Accelerate PhenoTest BC Kit |
| Classification | Positive Blood Culture Identification And Ast Kit |
| Applicant | Accelerate Diagnostics, Inc. 3950 S. Country Club Road #470 Tucson, AZ 85714 |
| Contact | Carrene Plummer |
| Correspondent | Carrene Plummer Accelerate Diagnostics, Inc. 3950 S. Country Club Road #470 Tucson, AZ 85714 |
| Product Code | PRH |
| Subsequent Product Code | LON |
| Subsequent Product Code | NSU |
| Subsequent Product Code | PAM |
| Subsequent Product Code | PEN |
| Subsequent Product Code | PEO |
| CFR Regulation Number | 866.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2020-09-15 |