The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Ca 15-3 Ii.
| Device ID | K181492 |
| 510k Number | K181492 |
| Device Name: | Elecsys CA 15-3 II |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | Roche Diagnostics 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250 |
| Contact | Adennis Cora |
| Correspondent | Adennis Cora Roche Diagnostics 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-06 |
| Decision Date | 2018-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336218334 | K181492 | 000 |