Aquios CL Flow Cytometer, Aquios TETRA-1 Panel,Aquios TETRA-2+PANEL, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios
FDA 510(k) K141932 · Beckman Coulter, Inc.
Submission
- Device name
- Aquios CL Flow Cytometer, Aquios TETRA-1 Panel,Aquios TETRA-2+PANEL, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios
- Applicant
- Beckman Coulter, Inc.
Miami, FL, US - Received
- July 16, 2014
- Decision date
- April 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OYE – Flow Cytometric Reagents And Accessories.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
Other 510(k)s with product code OYE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C PanelsOYE · Traditional | Beckman Coulter, Inc. | 11/22/2023SE |
| K201814 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…OYE · Traditional | Becton, Dickinson and Company | 09/28/2020SE |
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…OYE · Traditional | Becton, Dickinson and Company | 07/03/2017SE |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…OYE · Traditional | Beckman Coulter | 06/23/2017SE |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…OYE · Traditional | Bd Biosciences | 02/27/2015SE |
| K130373 | Navios Flow Cytometer SystemOYE · Traditional | Beckman Coulter, Inc. | 09/18/2013SE |
| K121445 | Tetrachrome Reagents and Tetracxp SystemOYE · Special | Beckman Coulter, Inc. | 07/26/2013SE |
More from Beckman Coulter, 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 Aquios CL Flow Cytometer, Aquios TETRA-1 Panel,Aquios TETRA-2+PANEL, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios cleared by the FDA?
Aquios CL Flow Cytometer, Aquios TETRA-1 Panel,Aquios TETRA-2+PANEL, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios (K141932) received a 510(k) decision of Substantially Equivalent on April 10, 2015, 268 days after the submission was received.
What is the product code of K141932?
The FDA product code is OYE – Flow Cytometric Reagents And Accessories., a Class II (moderate risk) device regulated under 21 CFR 864.5220.