The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect B12.
| Device ID | K984108 |
| 510k Number | K984108 |
| Device Name: | ABBOTT ARCHITECT B12 |
| Classification | Radioassay, Intrinsic Factor Blocking Antibody |
| Applicant | ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Contact | Laura L Granitz |
| Correspondent | Laura L Granitz ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Product Code | LIG |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-17 |
| Decision Date | 1999-02-03 |
| Summary: | summary |