K834594 is an FDA 510(k) clearance for the TOTAL IGE FAST TEST. This device is classified as a Ige, Antigen, Antiserum, Control (Class II - Special Controls, product code DGC).
Submitted by Allergenetics (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984, 43 days after receiving the submission on December 29, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K834594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1983 |
| Decision Date | February 10, 1984 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DGC — Ige, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |