The following data is part of a premarket notification filed by Diagnostica, Inc. with the FDA for Dermatophytin O.
| Device ID | K790671 |
| 510k Number | K790671 |
| Device Name: | DERMATOPHYTIN O |
| Classification | Kit, Identification, Yeast |
| Applicant | DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-06 |
| Decision Date | 1979-05-31 |