The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Precicontrol Multimarker.
| Device ID | K102157 |
| 510k Number | K102157 |
| Device Name: | ELECSYS PRECICONTROL MULTIMARKER |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Sarah Baumann |
| Correspondent | Sarah Baumann Roche Diagnostics 9115 HAGUE ROAD 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 | 2010-07-30 |
| Decision Date | 2010-08-27 |
| Summary: | summary |