AU5800(R) Chemistry Analyzer
FDA 510(k) K112412 · Beckman Coulter, Inc.
510(k) numberK112412
Submission
- Device name
- AU5800(R) Chemistry Analyzer
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- August 22, 2011
- Decision date
- December 23, 2011
- 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 |
| 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 |
| K112408 | Poly-Chem 90 Ise ModuleCEM · Traditional | Polymedco, Inc. | 11/04/2011SE |
More from Polymedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was AU5800(R) Chemistry Analyzer cleared by the FDA?
AU5800(R) Chemistry Analyzer (K112412) received a 510(k) decision of Substantially Equivalent on December 23, 2011, 123 days after the submission was received.
What is the product code of K112412?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.