GKEClass I

Osmotic Fragility Testing

21 CFR 864.6600 / Hematology

GKE is the FDA product code for Osmotic Fragility Testing, a class I device type, regulated under 21 CFR 864.6600. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code: GKE
Device name: Osmotic Fragility Testing
Regulation: 21 CFR 864.6600
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code GKE.

Recent clearances

Product code GKE

FDA records hold no clearances under product code GKE.

Recent recalls

Product code GKE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)