K984326 is an FDA 510(k) clearance for the ELECYS IGE ASSAY. This device is classified as a Radioimmunoassay, Immunoglobulins (d, E) (Class II - Special Controls, product code JHR).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 8, 1999, 67 days after receiving the submission on December 3, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K984326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1998 |
| Decision Date | February 08, 1999 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JHR — Radioimmunoassay, Immunoglobulins (d, E) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |