Navios Flow Cytometer System
FDA 510(k) K130373 · Beckman Coulter, Inc.
510(k) numberK130373
Submission
- Device name
- Navios Flow Cytometer System
- Applicant
- Beckman Coulter, Inc.
Miami, FL, US - Received
- February 14, 2013
- Decision date
- September 18, 2013
- 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 |
| K141932 | Aquios CL Flow Cytometer, Aquios TETRA-1 Panel,Aquios TETRA-2+PANEL, Aquios Immuno-Trol…OYE · Traditional | Beckman Coulter, Inc. | 04/10/2015SE |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…OYE · Traditional | Bd Biosciences | 02/27/2015SE |
| K121445 | Tetrachrome Reagents and Tetracxp SystemOYE · Special | Beckman Coulter, Inc. | 07/26/2013SE |
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Questions and answers
When was Navios Flow Cytometer System cleared by the FDA?
Navios Flow Cytometer System (K130373) received a 510(k) decision of Substantially Equivalent on September 18, 2013, 216 days after the submission was received.
What is the product code of K130373?
The FDA product code is OYE – Flow Cytometric Reagents And Accessories., a Class II (moderate risk) device regulated under 21 CFR 864.5220.