SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
FDA 510(k) K200544 · Diamond Diagnostics, Inc.
510(k) numberK200544
Submission
- Device name
- SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
- Applicant
- Diamond Diagnostics, Inc.
Holliston, MA, US - Received
- March 3, 2020
- Decision date
- October 1, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEM – Electrode, Ion Specific, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | Roche Diagnostics | 02/12/2026SE |
| K241037 | ABL90 FLEX PLUS SystemCEM · Traditional | Radiometer Medicals Aps | 01/14/2025SE |
| K220396 | EasyStat 300CEM · Traditional | Medica Corporation | 09/26/2023SE |
| K230890 | ISE ElectrodesCEM · Special | Randox Laboratories, Ltd. | 09/08/2023SE |
| K121012 | Flexlab 3.6, Accelerator A3600CEM · Traditional | Inpeco S.P.A. | 08/31/2012SE |
| K121040 | Smartlyte Electrolyte AnalyzerCEM · Traditional | Diamond Diagnostics, Inc. | 08/30/2012SE |
| K112995 | Gem Premier 4000CEM · Traditional | Instrumentation Laboratory CO | 05/03/2012SE |
| K110520 | Biolis 12ICEM · Traditional | Tokyo Boeki Medisys, Inc. | 03/23/2012SE |
| K112412 | AU5800(R) Chemistry AnalyzerCEM · Traditional | Beckman Coulter, Inc. | 12/23/2011SE |
| K112408 | Poly-Chem 90 Ise ModuleCEM · Traditional | Polymedco, Inc. | 11/04/2011SE |
More from Polymedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133751 | Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsJIT · Traditional | 08/08/2014SE |
| K124009 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed…JJY · Traditional | 04/17/2013SE |
| K121027 | Diamond Calibrator Low, Diamond Calibrator HighJIT · Traditional | 12/20/2012SE |
| K121040 | Smartlyte Electrolyte AnalyzerCEM · Traditional | 08/30/2012SE |
| K121140 | Prolyte Electrolyte AnalyzerJGS · Traditional | 08/22/2012SE |
| K120591 | Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2JIT · Traditional | 04/17/2012SE |
| K103364 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual LevelJJY · Traditional | 05/06/2011SE |
| K102959 | Prolyte Electrolyte AnalyzerJGS · Traditional | 01/14/2011SE |
| K093357 | Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module…JIT · Traditional | 06/24/2010SE |
| K093492 | Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical CalibratorJJY · Traditional | 03/19/2010SE |
Questions and answers
When was SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ cleared by the FDA?
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (K200544) received a 510(k) decision of Substantially Equivalent on October 1, 2020, 212 days after the submission was received.
What is the product code of K200544?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.