The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Ige Ii Immunoassay.
| Device ID | K061970 |
| 510k Number | K061970 |
| Device Name: | ELECSYS IGE II IMMUNOASSAY |
| Classification | Radioimmunoassay, Immunoglobulins (d, E) |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | JHR |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-12 |
| Decision Date | 2006-08-31 |
| Summary: | summary |