Advanced RBC Application— 510(k) K171315
Substantially EquivalentCellaVision AB
FDA 510(k) clearance K171315 for Advanced RBC Application, Substantially Equivalent on 2017-08-01. 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
- Traditional
- Location
- Lund, SE
Recent devices under product code JOY
view all- K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
- K221309 — AI100 with Shonit
- K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
- K200595 — CellaVision DC-1, CellaVision DC-1 PPA
- K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application
More clearances from CellaVision AB
view all- K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
- K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
- K080595 — CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
- K033840 — CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
- K003301 — DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.