The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Ferritin.
| Device ID | K983759 |
| 510k Number | K983759 |
| Device Name: | ABBOTT ARCHITECT FERRITIN |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park,, IL 60064 -3537 |
| Contact | Laura Granitz |
| Correspondent | Laura Granitz ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park,, IL 60064 -3537 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-26 |
| Decision Date | 1998-12-07 |
| Summary: | summary |