The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys He4, Elecsys He4 Calset, Elecsys Precicontrol He4, Elecsys He4 Calcheck 5.
| Device ID | K112624 |
| 510k Number | K112624 |
| Device Name: | ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 |
| Classification | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Jane Phillips |
| Correspondent | Jane Phillips Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | OIU |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-08 |
| Decision Date | 2012-09-10 |
| Summary: | summary |