The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries Group A Strep Assay, Aries Group A Strep Assay Protocol File Kit.
| Device ID | K172402 |
| 510k Number | K172402 |
| Device Name: | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Applicant | Luminex Corporation 12212 Technology Blvd. Austin, TX 78727 |
| Contact | Jennifer Grimes |
| Correspondent | Jennifer Grimes Luminex Corporation 12212 Technology Blvd. Austin, TX 78727 |
| Product Code | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-09 |
| Decision Date | 2017-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487101469 | K172402 | 000 |