ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
FDA 510(k) clearance K163626 · decided 2017-05-02
Clearance details
- K-number
- K163626
- Device name
- ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
- Applicant
- Luminex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-12-22
- Decision date
- 2017-05-02
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- OZZ
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 recall (Z-2282-2019) | Luminex Corporation | 2019-08-15 |