ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
FDA 510(k) clearance K151906 · decided 2015-10-06
Clearance details
- K-number
- K151906
- Device name
- ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
- 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
- PGI
- Device class
- 2
- Regulation number
- 866.3309
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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| Solana HSV 1+2/VZV Assay (K162451) | Quidel Corporation | 2016-11-28 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 recall (Z-2283-2019) | Luminex Corporation | 2019-08-15 |