5 devices · 4 companies · 2013 to 2026
Product code GKZ: Counter, Differential Cell
5 devices under product code GKZ, 2013 to 2026, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 5 here), the regulation, and MAUDE report counts by product code.
Counter, Differential Cell. 21 CFR 864.5220, Class II. MAUDE held 23,449 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Athelas HomeK243348 · 510(k) | Athelas, Inc. | Hematology | database entry | |
| Athelas HomeK200828 · 510(k) | Athelas Inc. | Hematology | database entry | |
| Sight OLOK190898 · 510(k) | Sight Diagnostics Ltd. | Hematology | database entry | |
| Athelas OneK181288 · 510(k) | Athelas Inc. | Hematology | database entry | |
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMK120771 · 510(k) | BECKMAN COULTER, INC. | Hematology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.