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510(k) K243144

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application by Scopio Labs , Ltd. — Product Code JOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell-Locating
Device Class
Class II
Regulation Number
864.5260
Review Panel
HE
Submission Type

Other clearances by Scopio Labs , Ltd.

  • DEN230034 — X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full F (March 22, 2024)
  • K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Applicatio (May 3, 2022)
  • K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application (October 2, 2020)

Other clearances for product code JOY

  • K221309 — AI100 with Shonit (September 19, 2023)
  • K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Applicatio (May 3, 2022)
  • K200595 — CellaVision DC-1, CellaVision DC-1 PPA (October 16, 2020)
  • K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application (October 2, 2020)
  • K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (October 30, 2018)
  • K171315 — Advanced RBC Application (August 1, 2017)
  • K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (September 16, 2011)
  • K092116 — EASYCELL CELL LOCATOR (May 12, 2010)
  • K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (November 20, 2009)
  • K080595 — CELLAVISION DM96 WITH THE BODY FLUID APPLICATION (December 5, 2008)