The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Xact Neisseria.
| Device ID | K880511 |
| 510k Number | K880511 |
| Device Name: | XACT NEISSERIA |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Contact | Ray Schneider |
| Correspondent | Ray Schneider AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-09 |
| Decision Date | 1988-08-25 |