DeviceClearance

Product code GKZ— Hematology

HemoScreen Hematology Analyzer

Classification name
Counter, Differential Cell
Device class
Class 2
Regulation
21 CFR 864.5220
Advisory panel
Hematology
Total cleared
380
First cleared
Most recent

Market context for product code GKZ

FDA has cleared 380 devices under product code GKZ between 1977 and 2026, filed by 90 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code GKZ

Adverse events under product code GKZ

product code GKZ
Malfunction
1,205
Total
1,205

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GKZ

1–100 of 380

Data sourced from openFDA. This site is unofficial and independent of the FDA.