The following data is part of a premarket notification filed by Allergenetics with the FDA for Allergentics Total Ige/theophylline.
| Device ID | K842970 |
| 510k Number | K842970 |
| Device Name: | ALLERGENTICS TOTAL IGE/THEOPHYLLINE |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ALLERGENETICS 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-08-29 |