The following data is part of a premarket notification filed by Technia Diagnostics Ltd. with the FDA for Ria Kit, Vitamin B12.
| Device ID | K782024 |
| 510k Number | K782024 |
| Device Name: | RIA KIT, VITAMIN B12 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | TECHNIA DIAGNOSTICS LTD. 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 | 1978-12-05 |
| Decision Date | 1979-02-28 |