The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Anti-tpo Calset.
| Device ID | K103171 |
| 510k Number | K103171 |
| Device Name: | ELECSYS ANTI-TPO CALSET |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50416 Indianapolis, IN 46250 -0416 |
| Contact | Sarah Baumann |
| Correspondent | Sarah Baumann Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50416 Indianapolis, IN 46250 -0416 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-27 |
| Decision Date | 2011-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630929696 | K103171 | 000 |