ARIES System
FDA 510(k) clearance K151917 · decided 2015-10-06
Clearance details
- K-number
- K151917
- Device name
- ARIES System
- Applicant
- Luminex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-07-13
- Decision date
- 2015-10-06
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- OOI
- Device class
- 2
- Regulation number
- 862.2570
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use recall (Z-2292-2019) | Luminex Corporation | 2019-08-19 |