Data / Medical devices / Israel / Pixcell Medical
Pixcell Medical: FDA-registered device maker in Yoknaem Ilit Northern, Israel, 3 510(k) clearances
Pixcell Medical is registered with the FDA (registration 3013608230) in Yoknaem Ilit Northern, Israel. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013608230
- Address
- 6 Hayezira St., Yoknaem Ilit Northern, Israel, 2069202
- Owner or operator
- PixCell Medical (10059178)
- Roles
- Manufacturer
- First device listed
- December 9, 2018
- Registered through
- 2026
- Brand names listed
- HemoCup, HemoScreen, HemoScreen Hematology Analyzer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Differential Cell | GKZ | 2 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 2, 2024 | K240636 | HemoScreen Hematology Analyzer | GKZ | Substantially Equivalent | Pixcell Medical Technologies | accessdata.fda.gov |
| August 16, 2023 | K222148 | HemoScreen Hematology Analyzer | GKZ | Substantially Equivalent | Pixcell Medical Technologies, Ltd. | accessdata.fda.gov |
| October 29, 2018 | K180020 | HemoScreen Hematology Analyzer | GKZ | Substantially Equivalent | Pixcell Medical Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Counter, Differential Cell
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Updated May 2, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.