GLP Systems Track

Electrode, Ion Specific, Sodium

Abbott Laboratories

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Glp Systems Track.

Pre-market Notification Details

• Device ID: K213486
• 510k Number: K213486
• Device Name: GLP Systems Track
• Classification: Electrode, Ion Specific, Sodium
• Applicant: Abbott Laboratories 100 Abbott Park Rd. Abbott Park, IL 60064
• Contact: Michele Smith Waheed
• Correspondent: Michele Smith-waheed; Abbott Laboratories 100 Abbott Park Rd. Abbott Park, IL 60064
• Product Code: JGS
• Subsequent Product Code: CEM
• Subsequent Product Code: CGZ
• Subsequent Product Code: JJE
• Subsequent Product Code: JQP
• CFR Regulation Number: 862.1665 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-10-29
• Decision Date: 2022-03-10