K931224 is an FDA 510(k) clearance for the VIDAS TOTAL IGE (IGE) ASSAY. This device is classified as a Ige, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DGP).
Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on May 20, 1993, 71 days after receiving the submission on March 10, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K931224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1993 |
| Decision Date | May 20, 1993 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DGP — Ige, Fitc, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |