Accelerate Pheno System, Accelerate PhenoTest BC Kit
FDA 510(k) clearance K192665 · decided 2020-09-15
Clearance details
- K-number
- K192665
- Device name
- Accelerate Pheno System, Accelerate PhenoTest BC Kit
- Applicant
- Accelerate Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-25
- Decision date
- 2020-09-15
- Days to decision
- 356 days
- Clearance type
- Traditional
- Product code
- PRH
- Device class
- 2
- Regulation number
- 866.1650
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Accelerate Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Accelerate Pheno system, Accelerate Phenotest BC Kit (DEN160032) | Accelerate Diagnotics | 2017-02-23 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Accelerate PhenoTest BC kit REF 10101018 recall (Z-0345-2023) | Accelerate Diagnostics Inc | 2022-12-06 |
| Accelerate PhenoTest BC kit REF 10102018 recall (Z-0346-2023) | Accelerate Diagnostics Inc | 2022-12-06 |