The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries System.
Device ID | K151917 |
510k Number | K151917 |
Device Name: | ARIES System |
Classification | Real Time Nucleic Acid Amplification System |
Applicant | LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin, TX 78727 |
Contact | Ronald Dunn |
Correspondent | Ronald Dunn LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin, TX 78727 |
Product Code | OOI |
CFR Regulation Number | 862.2570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-13 |
Decision Date | 2015-10-06 |