Accelerate Pheno System, Accelerate PhenoTest BC Kit— 510(k) K192665
Substantially EquivalentAccelerate Diagnostics, Inc.
FDA 510(k) clearance K192665 for Accelerate Pheno System, Accelerate PhenoTest BC Kit, Substantially Equivalent on 2020-09-15. Applicant: Accelerate Diagnostics, Inc..
Clearance details
- Applicant
- Accelerate Diagnostics, Inc.
- Product code
- Code PRH
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.