The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Rim-haemophilus 1 & 2.
| Device ID | K832051 |
| 510k Number | K832051 |
| Device Name: | RIM-HAEMOPHILUS 1 & 2 |
| Classification | Kit, Fastidious Organisms |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JST |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-24 |
| Decision Date | 1983-08-12 |