The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Precicontrol Varia 3.
| Device ID | K111506 |
| 510k Number | K111506 |
| Device Name: | ELECSYS PRECICONTROL VARIA 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50410 Indianapolis, IN 46250 -0416 |
| Contact | Sarah Baumann |
| Correspondent | Sarah Baumann Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50410 Indianapolis, IN 46250 -0416 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-01 |
| Decision Date | 2011-07-08 |
| Summary: | summary |