The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Rubella Igm Immunoassay.
| Device ID | K092322 |
| 510k Number | K092322 |
| Device Name: | ELECSYS RUBELLA IGM IMMUNOASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Theresa A Bush |
| Correspondent | Theresa A Bush Roche Diagnostics 9115 Hague Road 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 | 2009-08-04 |
| Decision Date | 2010-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336218440 | K092322 | 000 |