The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tan Dem* - Ige Kit.
| Device ID | K802913 |
| 510k Number | K802913 |
| Device Name: | TAN DEM* - IGE KIT |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | HYBRITECH, INC. 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 | 1980-11-18 |
| Decision Date | 1981-05-29 |