The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecys Cmv Igm Immunoassay; Elecys Precicontrol Cmv Igm.
| Device ID | K142133 |
| 510k Number | K142133 |
| Device Name: | ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | Roche Diagnostics 9155 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Sarah Baumann |
| Correspondent | Sarah Baumann Roche Diagnostics 9155 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 | 2014-08-04 |
| Decision Date | 2014-10-24 |
| Summary: | summary |