The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen, Vitamin B12 Assay System.
| Device ID | K792175 |
| 510k Number | K792175 |
| Device Name: | RIANEN, VITAMIN B12 ASSAY SYSTEM |
| Classification | Radioassay, Vitamin B12 |
| Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-29 |
| Decision Date | 1979-11-13 |