The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Rubella Igg Immunoassay.
| Device ID | K072617 |
| 510k Number | K072617 |
| Device Name: | ELECSYS RUBELLA IGG IMMUNOASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa A Bush |
| Correspondent | Theresa A Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2008-12-05 |
| Summary: | summary |