K061970 is an FDA 510(k) clearance for the ELECSYS IGE II IMMUNOASSAY. This device is classified as a Radioimmunoassay, Immunoglobulins (d, E) (Class II - Special Controls, product code JHR).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 31, 2006, 50 days after receiving the submission on July 12, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K061970 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2006 |
| Decision Date | August 31, 2006 |
| Days to Decision | 50 days |
| Submission Type | Special |
| 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 |