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.. Device class: 2.
Clearance details
- Applicant
- Accelerate Diagnostics, Inc.
- Product code
- Code PRH
- Device class
- Class 2
- Regulation
- 21 CFR 866.1650
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code PRH
view allMore clearances from Accelerate Diagnostics, Inc.
view allRecalls naming K192665
K-number listed on FDA's recall record- Z-0345-2023 — Accelerate PhenoTest BC kit REF 10101018
- Z-0346-2023 — Accelerate PhenoTest BC kit REF 10102018
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192665.
Data sourced from openFDA. This site is unofficial and independent of the FDA.