The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Cea.
| Device ID | K990774 |
| 510k Number | K990774 |
| Device Name: | ABBOTT ARCHITECT CEA |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Contact | Karen L Gates |
| Correspondent | Karen L Gates ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-09 |
| Decision Date | 1999-05-11 |
| Summary: | summary |