The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Toxo Igm, Elecsys Toxo Igm Precicontrol.
| Device ID | K162678 |
| 510k Number | K162678 |
| Device Name: | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kelli Turner |
| Correspondent | Kelli Turner ROCHE DIAGNOSTICS 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336218464 | K162678 | 000 |