BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
FDA 510(k) K170974 · Becton, Dickinson and Company
Submission
- Device name
- BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
- Applicant
- Becton, Dickinson and Company
San Jose, CA, US - Received
- April 3, 2017
- Decision date
- July 3, 2017
- 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.
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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 |
| 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 |
| K121445 | Tetrachrome Reagents and Tetracxp SystemOYE · Special | Beckman Coulter, Inc. | 07/26/2013SE |
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Questions and answers
When was BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK cleared by the FDA?
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK (K170974) received a 510(k) decision of Substantially Equivalent on July 3, 2017, 91 days after the submission was received.
What is the product code of K170974?
The FDA product code is OYE – Flow Cytometric Reagents And Accessories., a Class II (moderate risk) device regulated under 21 CFR 864.5220.