The following data is part of a premarket notification filed by Diagnostica, Inc. with the FDA for Aspergillus Fumigatus, Aspergillus Flavu.
| Device ID | K790672 |
| 510k Number | K790672 |
| Device Name: | ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU |
| Classification | Antigen, Cf, Aspergillus Spp. |
| Applicant | DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JWT |
| CFR Regulation Number | 866.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-06 |
| Decision Date | 1979-05-31 |