Product code JOY— Hematology
DUET SYSTEM
- Classification name
- Device, Automated Cell-Locating
- Device class
- Class 2
- Regulation
- 21 CFR 864.5260
- Advisory panel
- Hematology
- Total cleared
- 35
- First cleared
- Most recent
Market context for product code JOY
FDA has cleared devices under product code JOY between 1977 and 2025, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2023
- 2022
- 2020
- 2018
- 2017
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
Top applicants under product code JOY
Recent clearances under product code JOY
- K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
- K221309 — AI100 with Shonit
- K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
- K200595 — CellaVision DC-1, CellaVision DC-1 PPA
- K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application
- K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
- K171315 — Advanced RBC Application
- K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
- K092116 — EASYCELL CELL LOCATOR
- K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
- K080595 — CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
- K071398 — SCANVIEW, MODEL SC-300
- K061602 — DUET SYSTEM
- K062755 — IKONISCOPE ONCOFISH BLADDER TEST SYSTEM
- K061392 — IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM
- K052577 — IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
- K050840 — MODIFICATION TO DUET SYSTEM
- K040591 — DUET SYSTEM
- K033840 — CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
- K030192 — DUET SYSTEM
- K003301 — DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
- K001420 — SLIDESCAN
- K984188 — AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
- K982786 — TRACCELL 2000 SLIDE MAPPING SYSTEM
- K982301 — MICRO21 WITH URINE SEDIMENT ANALYSIS
- K980375 — WINSCAN AUTOMATED IMAGING SYSTEM
- K973050 — MICRO21 WITH WBC ESTIMATE
- K971470 — MICRO21 WITH CEREBROSPINAL FLUID
- K964689 — TRACCELL 2000 SLIDE MAPPING SYSTEM
- K970824 — MDX 2000, DIGITAL ANALYZER
- K960774 — MICRO21 WITH ANA
- K960776 — MICRO21 WITH RETIC
- K925670 — IMS-200
- K772139 — RE-CELL SLIDE RECAP
- K772140 — SCANNING SYS., AUTO. COMP., ACS1000
Data sourced from openFDA. This site is unofficial and independent of the FDA.