The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Vitamin B12 57co/folate 125i -.
| Device ID | K840462 |
| 510k Number | K840462 |
| Device Name: | VITAMIN B12 57CO/FOLATE 125I - |
| Classification | Radioassay, Vitamin B12 |
| Applicant | CORNING MEDICAL & SCIENTIFIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-02 |
| Decision Date | 1984-06-25 |