The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Radioassay, Control Serum I, Ii, Iii.
| Device ID | K790298 |
| 510k Number | K790298 |
| Device Name: | RADIOASSAY, CONTROL SERUM I, II, III |
| Classification | Whole Human Serum, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGR |
| CFR Regulation Number | 866.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-12 |
| Decision Date | 1979-04-04 |