The following data is part of a premarket notification filed by Luminex Corporation with the FDA for Aries Gbs Assay.
| Device ID | K162772 |
| 510k Number | K162772 |
| Device Name: | ARIES GBS Assay |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin, TX 78727 |
| Contact | Christie Hughes |
| Correspondent | Christie Hughes LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. Austin, TX 78727 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2016-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840487100165 | K162772 | 000 |