The following data is part of a premarket notification filed by Allergenetics with the FDA for Allergenetics Ige Fast Test.
| Device ID | K851512 |
| 510k Number | K851512 |
| Device Name: | ALLERGENETICS IGE FAST TEST |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | ALLERGENETICS 1500 SALADO DR. Mountain View, CA 94043 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay ALLERGENETICS 1500 SALADO DR. Mountain View, CA 94043 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-05-28 |