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510(k) K171315

Advanced RBC Application by CellaVision AB — Product Code JOY

K171315 is an FDA 510(k) premarket notification submitted by CellaVision AB for the device "Advanced RBC Application". The FDA issued a decision of Substantially Equivalent on August 1, 2017. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. CellaVision AB has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2017
Date Received
May 4, 2017
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 CellaVision AB

  • K200595 — CellaVision DC-1, CellaVision DC-1 PPA (October 16, 2020)
  • K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (September 16, 2011)
  • K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (November 20, 2009)
  • K080595 — CELLAVISION DM96 WITH THE BODY FLUID APPLICATION (December 5, 2008)
  • K033840 — CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER (February 10, 2004)
  • K003301 — DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER (March 15, 2001)

Other clearances for product code JOY

  • K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (June 27, 2025)
  • 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)
  • 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)

FDA data resources