Traccell 2000 Slide Mapping System
FDA 510(k) K964689 · Accumed Intl., Inc.
510(k) numberK964689
Submission
- Device name
- Traccell 2000 Slide Mapping System
- Applicant
- Accumed Intl., Inc.
Chicago, IL, US - Received
- November 22, 1996
- Decision date
- August 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K102778 | Cellavision DM1200 with the Body Fluid ApplictionJOY · Traditional | CellaVision AB | 09/16/2011SE |
| 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 |
More from CellaVision AB
| 510(k) | Device | Decision |
|---|---|---|
| K984489 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 02/16/1999SE |
| K983306 | Sensititre 18-24 Hour Susceptibility Plates with GrepafloxacinLTT · Traditional | 12/18/1998SE |
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | 12/17/1998SE |
| K983309 | Sensititre 19 - 24 Hour Susceptibility Plates with LevofloxacinLTT · Traditional | 12/14/1998SE |
| K983301 | Sensititre 18-24 Hour Susceptibility Plates with TrovafloxacinJWY · Traditional | 11/25/1998SE |
| K982786 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 10/16/1998SE |
| K972576 | Gram Positive Autoidentification Plates, Sensititre AP90LQL · Traditional | 01/22/1998SE |
| K972756 | Modification of Est Culture System II - MycoMDB · Traditional | 08/01/1997SE |
| K965190 | Sensititre Haemophilus/Streptococcus Pneumoniae Mic PlateJWY · Traditional | 03/19/1997SE |
| K960366 | Sensititre 18 Hour Susceptibility PlatesLTT · Traditional | 04/09/1996SE |
Questions and answers
When was Traccell 2000 Slide Mapping System cleared by the FDA?
Traccell 2000 Slide Mapping System (K964689) received a 510(k) decision of Substantially Equivalent on August 18, 1997, 269 days after the submission was received.
What is the product code of K964689?
The FDA product code is JOY – Device, Automated Cell-Locating, a Class II (moderate risk) device regulated under 21 CFR 864.5260.