510(k) K240854
- Device
- Accelerate Arc System
- Applicant
- Accelerate Diagnostics, Inc.
- 510(k) number
- K240854
- Product code
- QNJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-26
- Date received
- 2024-03-28
- Regulation
- 866.3378
- Classification name
- Mass Spectrometry, Microorganism Identification, Blood Culture
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jack Phillips
- Address
- 3950 S. Country Club Rd. Tucson AZ US 85714 85714
FDA Registration Numbers#
- 3003961381
- 3044320359
- 3010191749
- 3018426298
Source Documents#
Other 510(k) Records For Product Code QNJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193419 | MBT Sepsityper | Bruker Daltonik GmbH | 2020-12-27 |