RX Imola
FDA 510(k) K052914 · Randox Laboratories, Ltd.
510(k) numberK052914
Submission
- Device name
- RX Imola
- Applicant
- Randox Laboratories, Ltd.
Crumlin, GB - Received
- October 14, 2005
- Decision date
- March 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 01/23/2026SE |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 10/05/2023SE |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG · Traditional | 10/05/2023SE |
| K230890 | ISE ElectrodesCEM · Special | 09/08/2023SE |
| K182042 | Randox Calcium (Ca)CJY · Traditional | 10/23/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | 04/28/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | 04/21/2017SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | 03/20/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | 02/24/2016SE |
| K152343 | Direct BilirubinJFM · Traditional | 02/16/2016SE |
Questions and answers
When was RX Imola cleared by the FDA?
RX Imola (K052914) received a 510(k) decision of Substantially Equivalent on March 31, 2006, 168 days after the submission was received.
What is the product code of K052914?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.