SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

Electrode, Ion Specific, Potassium

Diamond Diagnostics Inc.

The following data is part of a premarket notification filed by Diamond Diagnostics Inc. with the FDA for Smartlyte® Plus Electrolyte Analyzer Na+/k+/cl-/ca++/li+.

Pre-market Notification Details

• Device ID: K200544
• 510k Number: K200544
• Device Name: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
• Classification: Electrode, Ion Specific, Potassium
• Applicant: Diamond Diagnostics Inc. 333 Fiske Street Holliston, MA 01746
• Contact: Kathy Fisher
• Correspondent: Kathy Fisher; Diamond Diagnostics Inc. 333 Fiske Street Holliston, MA 01746
• Product Code: CEM
• Subsequent Product Code: CGZ
• Subsequent Product Code: JFP
• Subsequent Product Code: JGS
• Subsequent Product Code: JIH
• Subsequent Product Code: JJE
• CFR Regulation Number: 862.1600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-03
• Decision Date: 2020-10-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811403010028	K200544	000