The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Archeitect Total B-hcg.
| Device ID | K983424 |
| 510k Number | K983424 |
| Device Name: | ABBOTT ARCHEITECT TOTAL B-HCG |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | ABBOTT LABORATORIES 100/200 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Karen L Gates |
| Correspondent | Karen L Gates ABBOTT LABORATORIES 100/200 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-29 |
| Decision Date | 1998-12-01 |
| Summary: | summary |