The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Precicontrol Ts.
| Device ID | K140534 |
| 510k Number | K140534 |
| Device Name: | ELECSYS PRECICONTROL TS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Jane Phillips |
| Correspondent | Jane Phillips Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-03-27 |
| Summary: | summary |