K800450 is an FDA 510(k) clearance for the GEMENI IGM ASSAY. This device is classified as a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II - Special Controls, product code DAO).
Submitted by Electro-Nucleonics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980, 55 days after receiving the submission on February 29, 1980.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K800450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 1980 |
| Decision Date | April 24, 1980 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAO — Igm (mu Chain Specific), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |