K760830 is an FDA 510(k) clearance for the ASPERGILLUS MYCELIAL ANTIGEN. This device is classified as a Antigen, Cf, Aspergillus Spp. (Class I - General Controls, product code JWT).
Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1976, 19 days after receiving the submission on October 13, 1976.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3040.
| 510(k) Number | K760830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1976 |
| Decision Date | November 01, 1976 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JWT — Antigen, Cf, Aspergillus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3040 |