SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+— 510(k) K200544

Substantially Equivalent

Diamond Diagnostics, Inc.

FDA 510(k) clearance K200544 for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+, Substantially Equivalent on 2020-10-01. Applicant: Diamond Diagnostics, Inc..

Clearance details

Applicant: Diamond Diagnostics, Inc.
Product code: Code CEM
Advisory panel: Clinical Chemistry
Date received: 2020-03-03
Decision date: 2020-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holliston, MA, US

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