Accelerate Arc System
FDA 510(k) clearance K240854 · decided 2024-09-26
Clearance details
- K-number
- K240854
- Device name
- Accelerate Arc System
- Applicant
- Accelerate Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-28
- Decision date
- 2024-09-26
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- QNJ
- Device class
- 2
- Regulation number
- 866.3378
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Accelerate Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MBT Sepsityper (K193419) | Bruker Daltonik GmbH | 2020-12-27 |
Recalls involving this device
No recalls on record reference this clearance.