The following data is part of a premarket notification filed by Biosan Laboratories, Inc. with the FDA for Tobramycin Reagent.
| Device ID | K832763 |
| 510k Number | K832763 |
| Device Name: | TOBRAMYCIN REAGENT |
| Classification | Radioimmunoassay, Tobramycin |
| Applicant | BIOSAN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLB |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-16 |
| Decision Date | 1984-03-23 |