The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Roche Diagnostics Cobas Elecsys Prolactin Ii Calset.
| Device ID | K052982 |
| 510k Number | K052982 |
| Device Name: | ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET |
| Classification | Calibrator, Secondary |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Randy Johnson |
| Correspondent | Randy Johnson Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-24 |
| Decision Date | 2005-10-28 |
| Summary: | summary |