510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OYEClass II

Flow Cytometric Reagents And Accessories.

21 CFR 864.5220 / Hematology
FDA source (opens on fda.gov)

OYE is the FDA product code for Flow Cytometric Reagents And Accessories., a class II device type, regulated under 21 CFR 864.5220. FDA's definition for this code reads: "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...". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 26 recalls.

Classification record

Product code
OYE
Device name
Flow Cytometric Reagents And Accessories.
FDA definition
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.
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
26

Clearances, product code OYE

By decision year
8 clearances under product code OYE with a decision year between 2013 and 2023, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OYE by decision year
YearClearances
20132
20152
20172
20201
20231

Applicants with the most clearances

Product code OYE
Applicants holding the most 510(k) clearances under product code OYE
ApplicantClearances
Siemens Healthcare Diagnostics Inc.5
Becton Dickinson & Co2
Becton, Dickinson and Company, BD Biosciences1

Companies listing this code with FDA

Companies whose registered establishments list this code