The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries Bordetella Assay; Aries Bordetella Assay Protocol File Kit.
| Device ID | K163626 |
| 510k Number | K163626 |
| Device Name: | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit |
| Classification | Bordetella Pertussis Dna Assay System |
| Applicant | Luminex Corporation 12212 Technology Blvd Austin, TX 78727 |
| Contact | Kate Linak |
| Correspondent | Kate Linak Luminex Corporation 12212 Technology Blvd Austin, TX 78727 |
| Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487101452 | K163626 | 000 |