Cellavision DM1200 with the Body Fluid Appliction
FDA 510(k) K102778 · CellaVision AB
510(k) numberK102778
Submission
- Device name
- Cellavision DM1200 with the Body Fluid Appliction
- Applicant
- CellaVision AB
Fridley, MN, US - Received
- September 24, 2010
- Decision date
- September 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOY – Device, Automated Cell-Locating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5260
- Specialty
- Hematology
Other 510(k)s with product code JOY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional | Scopio Labs , Ltd. | 06/27/2025SE |
| K221309 | AI100 with ShonitJOY · Traditional | Sigtuple Technologies Pvt. , Ltd. | 09/19/2023SE |
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional | Scopio Labs , Ltd. | 05/03/2022SE |
| K200595 | CellaVision DC-1, CellaVision DC-1 PPAJOY · Traditional | CellaVision AB | 10/16/2020SE |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) ApplicationJOY · Traditional | Scopio Labs , Ltd. | 10/02/2020SE |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY · Traditional | Sysmex America, Inc. | 10/30/2018SE |
| K171315 | Advanced RBC ApplicationJOY · Traditional | CellaVision AB | 08/01/2017SE |
| K092116 | Easycell Cell LocatorJOY · Traditional | Medica Corp. | 05/12/2010SE |
| K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127JOY · Special | CellaVision AB | 11/20/2009SE |
| K080595 | Cellavision DM96 with the Body Fluid ApplicationJOY · Traditional | CellaVision AB | 12/05/2008SE |
More from CellaVision AB
| 510(k) | Device | Decision |
|---|---|---|
| K200595 | CellaVision DC-1, CellaVision DC-1 PPAJOY · Traditional | 10/16/2020SE |
| K171315 | Advanced RBC ApplicationJOY · Traditional | 08/01/2017SE |
| K092868 | Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127JOY · Special | 11/20/2009SE |
| K080595 | Cellavision DM96 with the Body Fluid ApplicationJOY · Traditional | 12/05/2008SE |
| K033840 | Cellavision DM96 Automatic Hematology AnalyzerJOY · Traditional | 02/10/2004SE |
| K003301 | Diffmaster Octavia Automatic Hematology AnalyzerJOY · Traditional | 03/15/2001SE |
Questions and answers
When was Cellavision DM1200 with the Body Fluid Appliction cleared by the FDA?
Cellavision DM1200 with the Body Fluid Appliction (K102778) received a 510(k) decision of Substantially Equivalent on September 16, 2011, 357 days after the submission was received.
What is the product code of K102778?
The FDA product code is JOY – Device, Automated Cell-Locating, a Class II (moderate risk) device regulated under 21 CFR 864.5260.