Cellavision DM96 with Body Fluid Application
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080595 FDA 510(k)
- FDA Product Code
- JOY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5260 FDA 510(k)
- Regulation Number
- 864.5260 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cellavision DM96 with Body Fluid Application is an Automated Cell-Locating Device (per FDA classification) designed for hematological analysis. It automates the identification, classification, and enumeration of cellular components in body fluids, including blood and other specimens, to support diagnostic evaluations in hematology.
This system is intended for use in clinical laboratories and medical settings, providing automated image analysis for cytological examination. Supplied as a reusable instrument with FDA 510(k) clearance and IVDR compliance, it operates under controlled conditions and requires appropriate training for operation. The device is classified as Class II under FDA regulations and is regulated under 21 CFR 864.5260 for automated cell-locating instruments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K080595 | Class II | Active |
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Manufacturer
- Manufacturer
- Cellavision AB
Sources (2)
- FDA 510(k) K080595 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026