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JOY — Device, Automated Cell-Locating Class II

FDA Device Classification

Classification Details

Product Code
JOY
Device Class
Class II
Regulation Number
864.5260
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243144scopio labsX100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationJune 27, 2025
K221309sigtuple technologies pvt.AI100 with ShonitSeptember 19, 2023
K220013scopio labsX100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicatioMay 3, 2022
K200595cellavisionCellaVision DC-1, CellaVision DC-1 PPAOctober 16, 2020
K201301scopio labsX100 with Full Field Peripheral Blood Smear (PBS) ApplicationOctober 2, 2020
K182062sysmex americaSysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceOctober 30, 2018
K171315cellavisionAdvanced RBC ApplicationAugust 1, 2017
K102778cellavisionCELLAVISION DM1200 WITH THE BODY FLUID APPLICTIONSeptember 16, 2011
K092116medicaEASYCELL CELL LOCATORMay 12, 2010
K092868cellavisionCELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127November 20, 2009
K080595cellavisionCELLAVISION DM96 WITH THE BODY FLUID APPLICATIONDecember 5, 2008
K071398applied spectral imagingSCANVIEW, MODEL SC-300October 4, 2007
K061602bioviewDUET SYSTEMJanuary 23, 2007
K062755ikonisysIKONISCOPE ONCOFISH BLADDER TEST SYSTEMJanuary 4, 2007
K061392ikonisysIKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEMAugust 1, 2006
K052577ikonisysIKONISCOPE FASTFISH AMNIO IMAGING SYSTEMJanuary 24, 2006
K050840bioviewMODIFICATION TO DUET SYSTEMAugust 16, 2005
K040591bioviewDUET SYSTEMSeptember 16, 2004
K033840cellavisionCELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZERFebruary 10, 2004
K030192bioviewDUET SYSTEMAugust 20, 2003