The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Rapid Identifi-method Neisseria Kit.
| Device ID | K830968 |
| 510k Number | K830968 |
| Device Name: | RAPID IDENTIFI-METHOD NEISSERIA KIT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES TX |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-28 |
| Decision Date | 1983-06-16 |