CELLAVISION DM96 WITH THE BODY FLUID APPLICATION— 510(k) K080595
Substantially EquivalentCellaVision AB
FDA 510(k) clearance K080595 for CELLAVISION DM96 WITH THE BODY FLUID APPLICATION, Substantially Equivalent on 2008-12-05. 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
- Minneapolis,, MN, US
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More clearances from CellaVision AB
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