510(k) DEN160032
- Device
- Accelerate Pheno system, Accelerate Phenotest BC Kit
- Applicant
- Accelerate Diagnotics
- 510(k) number
- DEN160032
- Product code
- PRH
- Decision
- Unknown (DENG)
- Decision date
- 2017-02-23
- Date received
- 2016-07-11
- Regulation
- 866.1650
- Classification name
- Positive Blood Culture Identification And Ast Kit
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- MAUREEN MENDE
- Address
- 3950 S. Country Club Rd. #470 Tucson AZ US 85714 85714
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PRH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192665 | Accelerate Pheno System, Accelerate PhenoTest BC Kit | Accelerate Diagnostics, Inc. | 2020-09-15 |