The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries Mrsa Assay.
| Device ID | K191742 |
| 510k Number | K191742 |
| Device Name: | ARIES MRSA Assay |
| Classification | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Applicant | Luminex Corporation 12212 Technology Blvd Austin, TX 78727 |
| Contact | Kate Linak |
| Correspondent | Kate Linak Luminex Corporation 12212 Technology Blvd Austin, TX 78727 |
| Product Code | NQX |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487101445 | K191742 | 000 |