K240854
- 510(k) number
- K240854
- Device name
- Accelerate Arc System
- Applicant
- Accelerate Diagnostics, Inc. AZ · US
- Product code
- QNJ — Mass Spectrometry, Microorganism Identification, Blo
- Decision date
- 2024-09-26
- Date received
- 2024-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K240854.pdf
Official FDA record: K240854
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.