The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Rim-dnase Kit.
| Device ID | K841389 |
| 510k Number | K841389 |
| Device Name: | RIM-DNASE KIT |
| Classification | Culture Media, Single Biochemical Test |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES TX |
| Product Code | JSF |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-03 |
| Decision Date | 1984-05-02 |