The following data is part of a premarket notification filed by Allergenetics with the FDA for Labeled 125i Anti-ige.
| Device ID | K833419 |
| 510k Number | K833419 |
| Device Name: | LABELED 125I ANTI-IGE |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | ALLERGENETICS 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-03 |
| Decision Date | 1984-02-03 |