ARGOS

Counter, Differential Cell

ABX, INC.

The following data is part of a premarket notification filed by Abx, Inc. with the FDA for Argos.

Pre-market Notification Details

• Device ID: K895127
• 510k Number: K895127
• Device Name: ARGOS
• Classification: Counter, Differential Cell
• Applicant: ABX, INC. 355 BUSINESS CENTER DR. Horsham, PA 19044
• Contact: Philippe Gadal
• Correspondent: Philippe Gadal; ABX, INC. 355 BUSINESS CENTER DR. Horsham, PA 19044
• Product Code: GKZ
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-08-17
• Decision Date: 1989-10-10