Data / Medical devices / United States / Pixcell Medical Inc.
Pixcell Medical Inc.: FDA-registered device maker in Davie, FL, United States, 3 510(k) clearances
Pixcell Medical Inc. is registered with the FDA (registration 3039523350) in Davie, FL, United States. It lists 1 device type. 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
- 3039523350
- Address
- 3921 Sw 47th Ave Ste 1004, Davie, FL, United States, 33314
- Owner or operator
- Pixcell Medical Inc. (10083503)
- Roles
- Repackager or relabeler
- First device listed
- November 25, 2021
- Registered through
- 2026
- Brand names listed
- HemoScreen Hematology Analizer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Differential Cell | GKZ | 2 | Repackager or relabeler | 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
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.