The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Axsym B12.
| Device ID | K051327 |
| 510k Number | K051327 |
| Device Name: | ABBOTT AXSYM B12 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -6095 |
| Contact | Margaret Prochniak |
| Correspondent | Margaret Prochniak ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -6095 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-20 |
| Decision Date | 2005-08-03 |
| Summary: | summary |