The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries Hsv 1&2 Assay Cassettes - Carton Of 24 (ivd), Aries Hsv 1&2 Assay Protocol File Kit (ivd), Aries Hsv 1&2 Assay Cassette (ivd).
| Device ID | K151906 |
| 510k Number | K151906 |
| Device Name: | ARIES HSV 1&2 Assay Cassettes - Carton Of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) |
| Classification | Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| 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 | PGI |
| CFR Regulation Number | 866.3309 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-13 |
| Decision Date | 2015-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487101537 | K151906 | 000 |
| 00840487100295 | K151906 | 000 |