The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries System.
| Device ID | K160517 |
| 510k Number | K160517 |
| Device Name: | ARIES System |
| Classification | Real Time Nucleic Acid Amplification System |
| Applicant | LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin, TX 78727 |
| Contact | Wendy Ricker |
| Correspondent | Wendy Ricker 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 | 2016-02-24 |
| Decision Date | 2016-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487100073 | K160517 | 000 |