The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Alinity I Total ß-hcg Reagent Kit, Alinity I System.
| Device ID | K170317 |
| 510k Number | K170317 |
| Device Name: | Alinity I Total ß-hCG Reagent Kit, Alinity I System |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | ABBOTT LABORATORIES DEPT. 09AA, BLDG AP8 100 ABBOTT PARK ROAD Abbott Park, IL 60064 |
| Contact | Linda Sohn |
| Correspondent | Linda Sohn ABBOTT LABORATORIES DEPT. 09AA, BLDG AP8 100 ABBOTT PARK ROAD Abbott Park, IL 60064 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-01 |
| Decision Date | 2017-10-23 |
| Summary: | summary |