510(k) K092868
- Device
- CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
- Applicant
- CELLAVISION AB
- 510(k) number
- K092868
- Product code
- JOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-20
- Date received
- 2009-09-18
- Regulation
- 864.5260
- Classification name
- Device, Automated Cell-locating
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CONSTANCE G BUNDY
- Address
- 435 Rice Creek Ter. NE Fridley MN US 55432 55432
FDA Registration Numbers#
- 9615060
- 9613959
- 3003909093
- 3018182832
- 3010421384
- 3003630693
- 3009711478
- 3009834076
- 3020704087
- 3010960914
Source Documents#
Other 510(k) Records For Product Code JOY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2025-06-27 |
| K221309 | AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. | 2023-09-19 |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2022-05-03 |
| K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | 2020-10-16 |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2020-10-02 |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | Sysmex America, Inc. | 2018-10-30 |
| K171315 | Advanced RBC Application | CellaVision AB | 2017-08-01 |
| K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | CellaVision AB | 2011-09-16 |
| K092116 | EASYCELL CELL LOCATOR | Medica Corp. | 2010-05-12 |
| K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | CellaVision AB | 2008-12-05 |
| K071398 | SCANVIEW, MODEL SC-300 | Applied Spectral Imaging , Ltd. | 2007-10-04 |
| K061602 | DUET SYSTEM | Bioview , Ltd. | 2007-01-23 |
| K062755 | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM | Ikonisys, Inc. | 2007-01-04 |
| K061392 | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM | Ikonisys, Inc. | 2006-08-01 |
| K052577 | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM | Ikonisys, Inc. | 2006-01-24 |
Legacy Summary#
summary
FDA Review#
Decision Summary