The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Cmv Igm.
| Device ID | K163569 |
| 510k Number | K163569 |
| Device Name: | Elecsys CMV IgM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | Roche Diagnostics 9115 Hague Rd. Indianapolis, IN 46250 |
| Contact | Angelo Pereira |
| Correspondent | Angelo Pereira Roche Diagnostics 9115 Hague Rd. Indianapolis, IN 46250 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-03-17 |
| Summary: | summary |