CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127— 510(k) K092868
Substantially EquivalentCellaVision AB
FDA 510(k) clearance K092868 for CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127, Substantially Equivalent on 2009-11-20. Applicant: CellaVision AB. Device class: 2.
Clearance details
- Applicant
- CellaVision AB
- Product code
- Code JOY
- Device class
- Class 2
- Regulation
- 21 CFR 864.5260
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fridley, MN, US
Recent devices under product code JOY
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- K200595 — CellaVision DC-1, CellaVision DC-1 PPA
- K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application
More clearances from CellaVision AB
view allRecalls naming K092868
K-number listed on FDA's recall record- Z-0542-2026 — REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
- Z-2184-2018 — CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092868.
Data sourced from openFDA. This site is unofficial and independent of the FDA.