The following data is part of a premarket notification filed by Micromedic Systems with the FDA for Auto Pak Vitamin B-12.
| Device ID | K790347 |
| 510k Number | K790347 |
| Device Name: | AUTO PAK VITAMIN B-12 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | MICROMEDIC SYSTEMS 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 | 1979-02-21 |
| Decision Date | 1979-09-27 |