The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Vitamin B12 Ii Assay, Elecsys Vitamin B12 Ii Calset.
| Device ID | K151786 |
| 510k Number | K151786 |
| Device Name: | Elecsys Vitamin B12 II Assay, Elecsys Vitamin B12 II CalSet |
| Classification | Radioassay, Vitamin B12 |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Kelli Turner |
| Correspondent | Kelli Turner Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-01 |
| Decision Date | 2015-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630940684 | K151786 | 000 |
| 04015630939848 | K151786 | 000 |