SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+— 510(k) K200544
Substantially EquivalentDiamond 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.. Device class: 2.
Clearance details
- Applicant
- Diamond Diagnostics, Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holliston, MA, US
Recent devices under product code CEM
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- K121027 — DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
- K121040 — SMARTLYTE ELECTROLYTE ANALYZER
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Data sourced from openFDA. This site is unofficial and independent of the FDA.