K791387 is an FDA 510(k) clearance for the ASPERGILLUS MYCELIAL ANTIGEN #CF10024X. This device is classified as a Antigen, Cf, Aspergillus Spp. (Class I - General Controls, product code JWT).
Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979, 36 days after receiving the submission on July 11, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3040.
| 510(k) Number | K791387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1979 |
| Decision Date | August 16, 1979 |
| Days to Decision | 36 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 |