Electrolyte Analyzer
FDA 510(k) K851808 · Ionetics, Inc.
510(k) numberK851808
Submission
- Device name
- Electrolyte Analyzer
- Applicant
- Ionetics, Inc.
Costa Mesa, CA, US - Received
- April 15, 1985
- Decision date
- June 25, 1985
- 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 |
|---|---|---|
| K932179 | Model 400/450 Electrolyte AnalyzerJGS · Traditional | 11/17/1993SE |
| K895397 | Calcium and PH Electrolyte AnalyzerJFP · Traditional | 12/12/1989SE |
| K890792 | Potassium and Sodium Electrolyte AnalyzerCEM · Traditional | 05/03/1989SE |
| K863907 | Modified Sodium ElectrodeJGS · Traditional | 12/10/1986SE |
| K830130 | Miniature Ion Selective ElectrodesJSG · Traditional | 03/07/1983SE |
| K802856 | Miniature Ion Selective ElectrodesJFP · Traditional | 01/28/1981SE |
Questions and answers
When was Electrolyte Analyzer cleared by the FDA?
Electrolyte Analyzer (K851808) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 71 days after the submission was received.
What is the product code of K851808?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.