The following data is part of a premarket notification filed by Allergenetics with the FDA for Allergenetics Aller-specific Ige Serum.
| Device ID | K842969 |
| 510k Number | K842969 |
| Device Name: | ALLERGENETICS ALLER-SPECIFIC IGE SERUM |
| Classification | Ige, Fitc, Antigen, Antiserum, Control |
| Applicant | ALLERGENETICS 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | DGP |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-08-28 |