The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries C. Difficile Assay Complete Kit, Aries C. Difficile Assay Protocol File Kit, Aries C. Difficile Assay Kit (24 Cassettes), Aries Stool Resuspension Kit.
| Device ID | K171441 |
| 510k Number | K171441 |
| Device Name: | ARIES C. Difficile Assay Complete Kit, ARIES C. Difficile Assay Protocol File Kit, ARIES C. Difficile Assay Kit (24 Cassettes), ARIES Stool Resuspension Kit |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| 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 | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-16 |
| Decision Date | 2017-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487100059 | K171441 | 000 |