Tetrachrome Reagents and Tetracxp System
FDA 510(k) K121445 · Beckman Coulter, Inc.
510(k) numberK121445
Submission
- Device name
- Tetrachrome Reagents and Tetracxp System
- Applicant
- Beckman Coulter, Inc.
Miami, FL, US - Received
- May 15, 2012
- Decision date
- July 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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|---|---|---|---|
| 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 |
| K130373 | Navios Flow Cytometer SystemOYE · Traditional | Beckman Coulter, Inc. | 09/18/2013SE |
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Questions and answers
When was Tetrachrome Reagents and Tetracxp System cleared by the FDA?
Tetrachrome Reagents and Tetracxp System (K121445) received a 510(k) decision of Substantially Equivalent on July 26, 2013, 437 days after the submission was received.
What is the product code of K121445?
The FDA product code is OYE – Flow Cytometric Reagents And Accessories., a Class II (moderate risk) device regulated under 21 CFR 864.5220.