The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for No-boil Vitabin B12 5760 Folate 125i.
| Device ID | K813183 |
| 510k Number | K813183 |
| Device Name: | NO-BOIL VITABIN B12 5760 FOLATE 125I |
| Classification | Radioassay, Vitamin B12 |
| Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1981-11-16 |
| Decision Date | 1982-03-05 |