The following data is part of a premarket notification filed by Bio-rad with the FDA for Fluoromatic Tobramycin Fia Immunoassay.
| Device ID | K791596 |
| 510k Number | K791596 |
| Device Name: | FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY |
| Classification | Radioimmunoassay, Tobramycin |
| Applicant | BIO-RAD 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 | 1979-08-15 |
| Decision Date | 1979-10-17 |