The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad 125i Antiserum To Human Ige.
| Device ID | K812414 |
| 510k Number | K812414 |
| Device Name: | KALLESTAD 125I ANTISERUM TO HUMAN IGE |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-21 |
| Decision Date | 1981-09-14 |