Cellavision AB
Durham, NC, US
CELLAVISION AB appears in FDA device records in Durham, NC. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Cellavision AB between 2001 and 2020. The busiest year on record is 2001, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2004 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200595 | CellaVision DC-1, CellaVision DC-1 PPA | JOY | Substantially Equivalent | |
| K171315 | Advanced RBC Application | JOY | Substantially Equivalent | |
| K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | JOY | Substantially Equivalent | |
| K092868 | CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 | JOY | Substantially Equivalent | |
| K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | JOY | Substantially Equivalent | |
| K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | JOY | Substantially Equivalent | |
| K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | JOY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003630693 | 3003630693 | CELLAVISION AB | Mobilvagen 12, LUND Skane SE-22362 SE | 2026 | |
| 3003463647 | 3003463647 | CELLAVISION, INC. | 2530 Meridian Pkwy Ste 300, Durham, NC 27713 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results. | Class II | Open, Classified | |
| 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 | A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain