Sodium/Potassium Reagent Kits
FDA 510(k) K811310 · Chem-Elec, Inc.
510(k) numberK811310
Submission
- Device name
- Sodium/Potassium Reagent Kits
- Applicant
- Chem-Elec, Inc.
Mchenry, IL, US - Received
- May 11, 1981
- Decision date
- July 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEM · Traditional | Diamond Diagnostics, Inc. | 10/01/2020SE |
| 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 |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943503 | Chemcard Glucose TestCGA · Traditional | 07/23/1996SE |
| K864159 | Solid Phase Deter Serum Cholesterol FR Whole BloodCHH · Traditional | 06/10/1988SE |
| K811406 | Creatinine Rate Reagent KitCGX · Traditional | 08/13/1981SE |
| K811381 | AstraJFL · Traditional | 08/13/1981SE |
| K811319 | Chloride Reagent KitJFS · Traditional | 08/13/1981SE |
| K811165 | Glucose Oxidase Rate ReagentCGA · Traditional | 08/13/1981SE |
| K811193 | Bun Rate ReagentCDS · Traditional | 07/10/1981SE |
| K811701 | Chloride/Carbon Dioxide Rate ReagentJFS · Traditional | 07/01/1981SE |
Questions and answers
When was Sodium/Potassium Reagent Kits cleared by the FDA?
Sodium/Potassium Reagent Kits (K811310) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 60 days after the submission was received.
What is the product code of K811310?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.