K842749 is an FDA 510(k) clearance for the FIAX TOTAL IGE TEST KIT. This device is classified as a Ige, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DGP).
Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984, 46 days after receiving the submission on July 13, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K842749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1984 |
| Decision Date | August 28, 1984 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DGP — Ige, Fitc, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |