FDA Product Code
FDA Product Code JOY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5260
510(k) Clearances — 35 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2025-06-27 | Traditional | PDF ↗ |
| K221309 | AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. | 2023-09-19 | Traditional | PDF ↗ |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2022-05-03 | Traditional | PDF ↗ |
| K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | 2020-10-16 | Traditional | PDF ↗ |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2020-10-02 | Traditional | PDF ↗ |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | Sysmex America, Inc. | 2018-10-30 | Traditional | PDF ↗ |
| K171315 | Advanced RBC Application | CellaVision AB | 2017-08-01 | Traditional | PDF ↗ |
| K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | CellaVision AB | 2011-09-16 | Traditional | PDF ↗ |
| K092116 | EASYCELL CELL LOCATOR | Medica Corp. | 2010-05-12 | Traditional | PDF ↗ |
| K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | CellaVision AB | 2009-11-20 | Special | PDF ↗ |
| K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | CellaVision AB | 2008-12-05 | Traditional | PDF ↗ |
| K071398 | SCANVIEW, MODEL SC-300 | Applied Spectral Imaging , Ltd. | 2007-10-04 | Traditional | PDF ↗ |
| K061602 | DUET SYSTEM | Bioview , Ltd. | 2007-01-23 | Traditional | PDF ↗ |
| K062755 | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | Ikonisys, Inc. | 2007-01-04 | Traditional | PDF ↗ |
| K061392 | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | Ikonisys, Inc. | 2006-08-01 | Traditional | PDF ↗ |
| K052577 | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | Ikonisys, Inc. | 2006-01-24 | Traditional | PDF ↗ |
| K050840 | MODIFICATION TO DUET SYSTEM | Bioview , Ltd. | 2005-08-16 | Traditional | PDF ↗ |
| K040591 | DUET SYSTEM | Bioview , Ltd. | 2004-09-16 | Traditional | PDF ↗ |
| K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | CellaVision AB | 2004-02-10 | Traditional | PDF ↗ |
| K030192 | DUET SYSTEM | Bioview , Ltd. | 2003-08-20 | Traditional | PDF ↗ |
| K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | CellaVision AB | 2001-03-15 | Traditional | PDF ↗ |
| K001420 | SLIDESCAN | Applied Imaging Corp. | 2000-08-30 | Traditional | PDF ↗ |
| K984188 | AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) | Chroma Vision Medical Systems, Inc. | 1999-07-28 | Traditional | PDF ↗ |
| K982786 | TRACCELL 2000 SLIDE MAPPING SYSTEM | Accumed Intl., Inc. | 1998-10-16 | Traditional | PDF ↗ |
| K982301 | MICRO21 WITH URINE SEDIMENT ANALYSIS | Triangle Biomedical Sciences, Inc. | 1998-08-07 | Traditional | PDF ↗ |
| K980375 | WINSCAN AUTOMATED IMAGING SYSTEM | Applied Imaging Corp. | 1998-06-09 | Traditional | PDF ↗ |
| K973050 | MICRO21 WITH WBC ESTIMATE | Triangle Biomedical Sciences, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K971470 | MICRO21 WITH CEREBROSPINAL FLUID | Triangle Biomedical Sciences, Inc. | 1997-09-16 | Traditional | PDF ↗ |
| K964689 | TRACCELL 2000 SLIDE MAPPING SYSTEM | Accumed Intl., Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K970824 | MDX 2000, DIGITAL ANALYZER | Shotwell & Carr, Inc. | 1997-05-30 | Traditional | PDF ↗ |
| K960774 | MICRO21 WITH ANA | Triangle Biomedical Sciences, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K960776 | MICRO21 WITH RETIC | Triangle Biomedical Sciences, Inc. | 1996-05-17 | Traditional | PDF ↗ |
| K925670 | IMS-200 | Intelligent Medica Imaging, Inc. | 1993-07-23 | Traditional | PDF ↗ |
| K772139 | RE-CELL SLIDE RECAP | Geometric Data, Div. Smithkline Corp. | 1978-01-05 | Traditional | PDF ↗ |
| K772140 | SCANNING SYS., AUTO. COMP., ACS1000 | Honeywell, Inc. | 1977-12-05 | Traditional | PDF ↗ |
Product code JOY · Class II · Hematology. Data: openFDA.