The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantitope 125-i Gentamicin Ria Kit.
| Device ID | K780323 |
| 510k Number | K780323 |
| Device Name: | QUANTITOPE 125-I GENTAMICIN RIA KIT |
| Classification | Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DJB |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-27 |
| Decision Date | 1978-03-17 |