Accelerate Pheno system, Accelerate Phenotest BC Kit
FDA 510(k) clearance DEN160032 · decided 2017-02-23
Clearance details
- K-number
- DEN160032
- Device name
- Accelerate Pheno system, Accelerate Phenotest BC Kit
- Applicant
- Accelerate Diagnotics
- Decision
- Unknown
- Date received
- 2016-07-11
- Decision date
- 2017-02-23
- Days to decision
- 227 days
- Clearance type
- Direct
- 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
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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 (K192665) | Accelerate Diagnostics, Inc. | 2020-09-15 |
Recalls involving this device
No recalls on record reference this clearance.