K802427 is an FDA 510(k) clearance for the LA-SPORO ANTIBODY SYSTEM. This device is classified as a Antisera, Fluorescent, Sporothrix Schenekii (Class I - General Controls, product code GMA).
Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980, 25 days after receiving the submission on October 6, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3680.
| 510(k) Number | K802427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1980 |
| Decision Date | October 31, 1980 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMA — Antisera, Fluorescent, Sporothrix Schenekii |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3680 |