DUET SYSTEM— 510(k) K061602
Substantially EquivalentBioview , Ltd.
FDA 510(k) clearance K061602 for DUET SYSTEM, Substantially Equivalent on 2007-01-23. Applicant: Bioview , Ltd.. Device class: 2.
Clearance details
- Applicant
- Bioview , Ltd.
- 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
- Tel Aviv, IL
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 Bioview , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.