The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Progesterone Iii Calset.
| Device ID | K152526 |
| 510k Number | K152526 |
| Device Name: | Elecsys Progesterone III CalSet |
| Classification | Calibrator, Secondary |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Patty Bates |
| Correspondent | Patty Bates ROCHE DIAGNOSTICS 9115 HAGUE ROAD 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 | 2015-09-03 |
| Decision Date | 2015-10-02 |
| Summary: | summary |