K790672 is an FDA 510(k) clearance for the ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU. This device is classified as a Antigen, Cf, Aspergillus Spp. (Class I - General Controls, product code JWT).
Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1979, 55 days after receiving the submission on April 6, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3040.
| 510(k) Number | K790672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1979 |
| Decision Date | May 31, 1979 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JWT — Antigen, Cf, Aspergillus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3040 |