The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Vitamin B12 Radioassay.
| Device ID | K761321 |
| 510k Number | K761321 |
| Device Name: | VITAMIN B12 RADIOASSAY |
| Classification | Radioassay, Vitamin B12 |
| Applicant | KALLESTAD LABORATORIES, INC. 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 | 1976-12-27 |
| Decision Date | 1977-03-21 |