The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries Mi System, Aries Hsv 1&2 Assay Cassettes-carton Of 24 (ivd), Aries Hsv 1&2 Assay Protocol File Kit (ivd).
| Device ID | K161495 |
| 510k Number | K161495 |
| Device Name: | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton Of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) |
| Classification | Real Time Nucleic Acid Amplification System |
| Applicant | LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin, TX 78727 |
| Contact | Christie Hughes |
| Correspondent | Christie Hughes LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin, TX 78727 |
| Product Code | OOI |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-06-30 |