The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Cmv Igg.
| Device ID | K220911 |
| 510k Number | K220911 |
| Device Name: | Elecsys CMV IgG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Bin Sun |
| Correspondent | Bin Sun Roche Diagnostics 9115 Hague Road 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 | 2022-03-29 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336198469 | K220911 | 000 |
| 07613336193082 | K220911 | 000 |