BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
FDA 510(k) K141468 · Bd Biosciences
Submission
- Device name
- BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
- Applicant
- Bd Biosciences
San Jose, CA, US - Received
- June 3, 2014
- Decision date
- February 27, 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.
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| K060375 | BD Multitest 6-COLOR TBNK Reagent with BD Trucount Tubes with Models 337 and 166GKZ · Traditional | 06/06/2006SE |
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Questions and answers
When was BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) cleared by the FDA?
BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (K141468) received a 510(k) decision of Substantially Equivalent on February 27, 2015, 269 days after the submission was received.
What is the product code of K141468?
The FDA product code is OYE – Flow Cytometric Reagents And Accessories., a Class II (moderate risk) device regulated under 21 CFR 864.5220.