ABL90 Flex Series
FDA 510(k) K092686 · Radiometer Medical Aps
510(k) numberK092686
Submission
- Device name
- ABL90 Flex Series
- Applicant
- Radiometer Medical Aps
Bronshoj, DK - Received
- September 2, 2009
- Decision date
- August 6, 2010
- 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 |
| K112412 | AU5800(R) Chemistry AnalyzerCEM · Traditional | Beckman Coulter, Inc. | 12/23/2011SE |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX · Traditional | 09/21/2017SE |
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | 04/28/2017SE |
| K160153 | ABL90 Flex PlusCHL · Special | 11/04/2016SE |
| K142898 | ABL800 FLEX with AQURE connectivityCHL · Special | 06/17/2015SE |
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | 05/13/2015SE |
| K132691 | ABL90 FlexMQM · Traditional | 11/13/2014SE |
| K131988 | ABL90 Flex AnalyzerCHL · Traditional | 09/17/2013SE |
| K130144 | ABL90 FlexCHL · Special | 07/31/2013SE |
| K123748 | ABL90 FlexCHL · Special | 05/07/2013SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | 03/26/2013SE |
Questions and answers
When was ABL90 Flex Series cleared by the FDA?
ABL90 Flex Series (K092686) received a 510(k) decision of Substantially Equivalent on August 6, 2010, 338 days after the submission was received.
What is the product code of K092686?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.