The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Ca 125 Ii Calset Ii.
| Device ID | K140112 |
| 510k Number | K140112 |
| Device Name: | CA 125 II CALSET II |
| Classification | Calibrator, Secondary |
| Applicant | Roche Diagnostics 9155 HAGUE RD. PO BOX 50416 Indianapolis, IN 46250 |
| Contact | Jane Ellen Phillips |
| Correspondent | Jane Ellen Phillips Roche Diagnostics 9155 HAGUE RD. PO BOX 50416 Indianapolis, IN 46250 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-15 |
| Decision Date | 2014-06-06 |
| Summary: | summary |