The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect B12 Reagents, Architect B12 Calibrators, And Architect B12 Controls.
| Device ID | K110579 |
| 510k Number | K110579 |
| Device Name: | ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS |
| Classification | Radioassay, Vitamin B12 |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 Abbott Park, IL 60064 |
| Contact | Darla Abano |
| Correspondent | Darla Abano ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 Abbott Park, IL 60064 |
| Product Code | CDD |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-01 |
| Decision Date | 2011-10-06 |
| Summary: | summary |