The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Precicontrol Cmv Igg, Elecsys Cmv Igg Immunoassay.
| Device ID | K131605 |
| 510k Number | K131605 |
| Device Name: | ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50416 Indianapolis, IN 46250 -0416 |
| Contact | Jane Phillips, Phd |
| Correspondent | Jane Phillips, Phd Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50416 Indianapolis, IN 46250 -0416 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2014-02-28 |
| Summary: | summary |