510(k) Premarket Notification

• Device Classification Name: System, Test, Human Chorionic Gonadotropin
• 510(k) Number: K170317
• Device Name: Alinity i Total ß-hCG Reagent Kit, Alinity i System
• Applicant: Abbott Laboratories; Dept. 09aa Bldg. Ap8; 100 Abbott Park Rd.; Abbott Park, IL 60064
• Applicant Contact: LINDA SOHN
• Correspondent: Abbott Laboratories; Dept. 09aa Bldg. Ap8; 100 Abbott Park Rd.; Abbott Park, IL 60064
• Correspondent Contact: LINDA SOHN
• Regulation Number: 862.1155
• Classification Product Code: DHA
• Subsequent Product Code: JJE
• Date Received: 02/01/2017
• Decision Date: 10/23/2017
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Clinical Chemistry
• 510k Review Panel: Clinical Chemistry
• Summary: Summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls