SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
K-Number: K200544 · 2020-10-01
ApplicantDiamond Diagnostics, Inc.
Decision Date2020-10-01
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is a medical device manufactured by Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-10-01 under approval number K200544. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is a medical device that received FDA 510(k) clearance on 2020-10-01. It is manufactured by Diamond Diagnostics, Inc.. The 510(k) number is K200544.
When was SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ approved by the FDA?
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ received FDA 510(k) clearance on 2020-10-01, under approval number K200544.
What company makes SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is manufactured by Diamond Diagnostics, Inc..
What is the FDA product code for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?
The FDA product code for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is CEM.
Related Devices (Code: CEM)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.